Actions of Turbo Cough in details
Pharmacotherapeutic Group: Nasal decongestants for systemic use. ATC Code: R01B A52.
Pharmacology: Pharmacodynamics: Mechanism of Action: Cetirizine (Turbo Cough): In animal studies, Cetirizine (Turbo Cough) acts as a H1-antagonist devoid of significant anticholinergic and antiserotoninergic effects. In pharmacologically active doses, it induces neither sedation nor behavioural changes, which may be due to the absence of passage through the blood-brain barrier. Pseudoephedrine (Turbo Cough): A stereoisomer of ephedrine, is an orally active sympathomimetic, whose α-mimetic effects are greater than its β-mimetic activity; due to its vasoconstrictor action, it has a decongestant effect on the nasal mucosa.
Pharmacodynamic Effects: Cetirizine (Turbo Cough): In human pharmacological studies, Cetirizine (Turbo Cough) has been shown capable of inhibiting some of the effects of exogenous histamine. The onset of this action is rapid. Cetirizine (Turbo Cough) also inhibits the effects of endogenous histamine liberated in vivo by a histamine-releasing agent eg, compound 48/80 (synthetic polyamine, condensation product of N-methyl-p-methoxyphenylethylamine with formaldehyde). In addition, it inhibits the skin reaction induced by vasoactive intestinal polypeptide (VIP) and substance P, both of which are neuropeptides considered to be involved in the allergic reaction. Cetirizine (Turbo Cough) inhibits the histamine-mediated early phase of the allergic reaction. It also significantly inhibits the migration of inflammatory cells (including eosinophils) and the release of mediators associated with the late allergic response.
Moreover, it reduces the allergic reaction caused by specific antigens. These effects are achieved without any objective effect on the central nervous system, either in psychometric tests or in the quantitative EEG.
Pseudoephedrine (Turbo Cough): In recommended doses, it can induce other sympathomimetic effects eg, a rise in blood pressure, tachycardia or symptoms of central excitation eg, insomnia.
Clinical Studies: Not relevant.
Pharmacokinetics: There was no evidence for a relevant pharmacokinetic interaction between Cetirizine (Turbo Cough) and Pseudoephedrine (Turbo Cough).
Absorption and Distribution: Cetirizine (Turbo Cough): After oral administration, Cetirizine (Turbo Cough) is rapidly and almost completely absorbed. Peak plasma concentrations (Cmax) are generally obtained within 1 hr under fasting conditions. The absorption is independent of the dose. Inter- and intrasubjects variations are low. Cetirizine (Turbo Cough) is highly bound to plasma proteins (93%). Its volume of distribution is small: Approximately 0.5 L/kg.
Pseudoephedrine (Turbo Cough): Pseudoephedrine (Turbo Cough) given as the sustained-release formulation Turbo Cough provides maximum plasma levels 2-6 hrs after multiple dosing.
Metabolism and Elimination: Cetirizine (Turbo Cough): Cetirizine (Turbo Cough) does not undergo any appreciable first-pass metabolism. The plasma half-life (t½) of Cetirizine (Turbo Cough) is approximately 9 hrs. This value is increased in patients with reduced renal function. After repeated oral administration, the daily urinary excretion of unchanged Cetirizine (Turbo Cough) is approximately 65% of the dose. The elimination is independent of the dose.
Pseudoephedrine (Turbo Cough): It is excreted mainly unchanged in the urine. The rate of urinary excretion is increased when the pH of urine is reduced, and reduced in case of alkalinization of urine. After repeated oral administration (every 12 hrs), at steady-state, the apparent elimination t½ is estimated to be approximately 9 hrs.
Special Patient Populations: Renal Impairment: The dose should be reduced to ½ the usual recommended dose.
Toxicology: Preclinical Data: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute toxicology, repeated-dose toxicity and genotoxicity.
In reproductive toxicity studies in rats, a slight increase in pup mortality from birth and a reduction in body weight of selected F1 generation males were observed at maternally toxic doses. This dose (40 mg/kg/day) represents a systemic exposure to Pseudoephedrine (Turbo Cough) which is above the therapeutic exposure in humans. The relevance of this observation for the safe use in humans during pregnancy and lactation remains unknown.
How should I take Turbo Cough?
This section provides information on the proper use of a number of products that contain cough and cold combinations. It may not be specific to Turbo Cough. Please read with care.
To help loosen mucus or phlegm in the lungs, drink a glass of water after each dose of this medicine, unless otherwise directed by your doctor.
Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.
Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects.
For patients taking the extended-release capsule or tablet form of this medicine:
- Swallow the capsule or tablet whole.
- Do not crush, break, or chew before swallowing.
- If the capsule is too large to swallow, you may mix the contents of the capsule with applesauce, jelly, honey, or syrup and swallow without chewing.
For patients taking the extended-release oral solution or oral suspension form of this medicine:
- Do not dilute with fluids or mix with other drugs.
For patients taking a combination medicine containing an antihistamine and/or aspirin or other salicylate:
- Take with food or a glass of water or milk to lessen stomach irritation, if necessary.
If a combination medicine containing aspirin has a strong vinegar-like odor, do not use it. This odor means the medicine is breaking down. If you have any questions about this, check with your pharmacist.
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not keep outdated medicine or medicine no longer needed.
Keep the liquid form of this medicine from freezing. Do not refrigerate the syrup.
Turbo Cough administration
Take this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.
Take one tablet every 12 hours, unless your doctor tells you otherwise. You may take this medication with or without food.
Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking or opening the pill may cause too much of the medicine to be released at one time.
Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.
Store Cetirizine (Turbo Cough) and Pseudoephedrine (Turbo Cough) at room temperature away from moisture and heat.
Turbo Cough pharmacology
Mechanisms of Action
Cetirizine (Turbo Cough), a metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of H receptors.
Pseudoephedrine (Turbo Cough) hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. Pseudoephedrine (Turbo Cough) hydrochloride is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. Pseudoephedrine (Turbo Cough) 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.
Pharmacokinetics
Absorption
The bioavailability of Cetirizine (Turbo Cough) hydrochloride and Pseudoephedrine (Turbo Cough) hydrochloride from Turbo Cough (Cetirizine (Turbo Cough), Pseudoephedrine (Turbo Cough)) Tablets is not significantly different from that achieved with separate administration of a Cetirizine (Turbo Cough) 5 mg tablet and a Pseudoephedrine (Turbo Cough) 120 mg extended release caplet. Co-administration of Cetirizine (Turbo Cough) and Pseudoephedrine (Turbo Cough) does not significantly affect the bioavailability of either component.
Following a single dose of the Turbo Cough (Cetirizine (Turbo Cough), Pseudoephedrine (Turbo Cough)) Tablet, a mean peak plasma concentration (Cmax) of 114 ng/mL at a time (Tmax) of 2.2 hours postdose was observed for Cetirizine (Turbo Cough) and a mean Cmax of 309 ng/mL at a Tmax of 4.4 hours postdose was observed for Pseudoephedrine (Turbo Cough).
When healthy volunteers were administered multiple doses of the Turbo Cough (Cetirizine (Turbo Cough), Pseudoephedrine (Turbo Cough)) Tablet to reach steady-state concentrations (Cetirizine (Turbo Cough) hydrochloride 5 mg and Pseudoephedrine (Turbo Cough) hydrochloride 120 mg twice daily for seven days), a mean Cmax of 178 ng/mL was observed for Cetirizine (Turbo Cough) and 526 ng/mL for Pseudoephedrine (Turbo Cough).
Food had no significant effect on the extent of Cetirizine (Turbo Cough) absorption (AUC), but Tmax was delayed by 1.8 hours and Cmax was decreased by 30%. Food had no significant effect on the pharmacokinetics of Pseudoephedrine (Turbo Cough). Turbo Cough (Cetirizine (Turbo Cough), Pseudoephedrine (Turbo Cough)) Tablets may be given with or without food.
Distribution
The mean plasma protein binding of Cetirizine (Turbo Cough) is 93%, independent of concentration in the range of 25-1000 ng/mL, which includes the therapeutic plasma levels observed. The apparent volume of distribution (V/F) of Pseudoephedrine (Turbo Cough) has been reported to be 2.6-3.3 L/kg. No plasma protein binding data in humans are available.
Metabolism
A human mass balance study of Cetirizine (Turbo Cough) in 6 healthy male volunteers indicated that 70% of the administered radioactivity was recovered in the urine and 10% in the feces. Approximately 50% of the radioactivity was identified in the urine as unchanged drug. Most of the rapid increase in peak plasma radioactivity was associated with parent drug, suggesting low first pass metabolism. Cetirizine (Turbo Cough) is metabolized to a limited extent by oxidative O-dealkylation to a metabolite with negligible antihistaminic activity. The enzyme or enzymes responsible for this metabolism have not been identified.
One to seven percent of the Pseudoephedrine (Turbo Cough) dose appeared to be metabolized to norpseudoephedrine by N-demethylation after a single dose.
Elimination
After administration of the Turbo Cough (Cetirizine (Turbo Cough), Pseudoephedrine (Turbo Cough)) Tablet, the mean elimination half-life of Cetirizine (Turbo Cough) was 7.9 hours and the mean elimination half-life of Pseudoephedrine (Turbo Cough) was 6.0 hours.
It was reported that 0.4-0.7% of the Pseudoephedrine (Turbo Cough) dose was estimated to be excreted in the breast milk over 24 hours after a single dose. The pattern of the relative milk/plasma drug concentration profile showed that Pseudoephedrine (Turbo Cough) concentrations in milk were 2- to 3-fold higher than those in plasma.
DRUG INTERACTIONS
Pharmacokinetic interaction trials with Cetirizine (Turbo Cough) in adults were conducted with Pseudoephedrine (Turbo Cough), antipyrine, ketoconazole, erythromycin and azithromycin. No interactions were observed. In a multiple dose study of theophylline (400 mg once daily for 3 days) and Cetirizine (Turbo Cough) (20 mg once daily for 3 days), a 16% decrease in the clearance of Cetirizine (Turbo Cough) was observed. The disposition of theophylline was not altered by concomitant Cetirizine (Turbo Cough) administration.
Special Populations
Pediatrics: Although Cetirizine (Turbo Cough) pharmacokinetics have been studied in children, Turbo Cough (Cetirizine (Turbo Cough), Pseudoephedrine (Turbo Cough)) Tablets contain 120 mg of Pseudoephedrine (Turbo Cough) hydrochloride, which exceeds the recommended dose for patients less than 12 years of age. Therefore, Turbo Cough (Cetirizine (Turbo Cough), Pseudoephedrine (Turbo Cough)) Tablets are not recommended for patients under 12 years of age.
Geriatrics: Following a single, 10-mg oral dose of Cetirizine (Turbo Cough), the elimination half-life was prolonged by 50% and the apparent total body clearance was 40% lower in 16 geriatric subjects with a mean age of 77 years compared to 14 adult subjects with a mean age of 53 years. The decrease in Cetirizine (Turbo Cough) clearance in these elderly volunteers may be related to decreased renal function.
The pharmacokinetics of Pseudoephedrine (Turbo Cough) has not been adequately studied in geriatric subjects.
Gender: The effect of gender on Cetirizine (Turbo Cough) or Pseudoephedrine (Turbo Cough) pharmacokinetics has not been adequately studied.
Race: The effect of race on Cetirizine (Turbo Cough) or Pseudoephedrine (Turbo Cough) pharmacokinetics has not been adequately studied.
Renal Impairment: The kinetics of Cetirizine (Turbo Cough) were studied following multiple, oral, 10-mg daily doses of Cetirizine (Turbo Cough) for 7 days in 7 normal volunteers (creatinine clearance 89-128 mL/min), 8 patients with mild renal function impairment (creatinine clearance 42-77 mL/min) and 7 patients with moderate renal function impairment (creatinine clearance 11-31 mL/min). The pharmacokinetics of Cetirizine (Turbo Cough) were similar in patients with mild impairment and normal volunteers. Moderately impaired patients had a 3-fold increase in half-life and a 70% decrease in clearance compared to normal volunteers.
Patients on hemodialysis (n=5) given a single, 10-mg dose of Cetirizine (Turbo Cough) had a 3-fold increase in half-life and a 70% decrease in clearance compared to normal volunteers. Less than 10% of the administered dose was removed during the single dialysis session.
About 55-75% of an administered dose of Pseudoephedrine (Turbo Cough) hydrochloride is excreted unchanged in the urine; the remainder is apparently metabolized in the liver. Therefore, Pseudoephedrine (Turbo Cough) may accumulate in patients with renal insufficiency.
Dosing adjustment is necessary in patients with moderate or severe renal impairment and in patients on dialysis.
Hepatic Impairment: Sixteen patients with chronic liver diseases (hepatocellular, cholestatic, and biliary cirrhosis), given 10 or 20 mg of Cetirizine (Turbo Cough) as a single, oral dose had a 50% increase in half-life along with a corresponding 40% decrease in clearance compared to 16 healthy subjects.
The effect of hepatic impairment on Pseudoephedrine (Turbo Cough) pharmacokinetics is unknown.
Dosing adjustment may be necessary in patients with hepatic impairment.
Pharmacodynamics: Trials in 69 adult normal volunteers (aged 20-61 years) showed that Cetirizine (Turbo Cough) at doses of 5 and 10 mg inhibited the skin wheal and flare caused by the intradermal injection of histamine. The onset of this activity after a single 10-mg dose occurred within 20 minutes in 50% of subjects and within one hour in 95% of subjects; this activity persisted for at least 24 hours. The effects of intradermal injection of various other mediators or histamine releasers were also inhibited by Cetirizine (Turbo Cough). In mildly asthmatic subjects, Cetirizine (Turbo Cough) at 5 to 20 mg blocked bronchoconstriction due to nebulized histamine, with virtually total blockade after a 20 mg dose. In trials conducted for up to 12 hours following cutaneous antigen challenge, the late phase recruitment of eosinophils, neutrophils and basophils, components of the allergic inflammatory response, was inhibited by Cetirizine (Turbo Cough) at a dose of 20 mg. The clinical significance of these findings is not known.
In four clinical trials in healthy adult males, no clinically significant mean increases in QTc were observed in Cetirizine (Turbo Cough) treated subjects. In the first study, a placebo-controlled crossover trial, Cetirizine (Turbo Cough) was given at doses up to 60 mg per day, 6 times the maximum clinical dose, for 1 week, and no significant mean QTc prolongation occurred. In the second study, a crossover trial, Cetirizine (Turbo Cough) 20 mg and erythromycin (500 mg every 8 hours) were given alone and in combination. There was no significant effect on QTc with the combination or with Cetirizine (Turbo Cough) alone. In the third trial, also a crossover study, Cetirizine (Turbo Cough) 20 mg and ketoconazole (400 mg per day) were given alone and in combination. Cetirizine (Turbo Cough) caused a mean increase in QTc of 9.1 msec from baseline after 10 days of therapy. Ketoconazole also increased QTc by 8.3 msec. The combination caused an increase of 17.4 msec, equal to the sum of the individual effects. Thus, there was no significant drug interaction on QTc with the combination of Cetirizine (Turbo Cough) and ketoconazole. In the fourth study, a placebo-controlled parallel trial, Cetirizine (Turbo Cough) 20 mg was given alone or in combination with azithromycin (500 mg as a single dose on the first day followed by 250 mg once daily). There was no significant increase in QTc with Cetirizine (Turbo Cough) 20 mg alone or in combination with azithromycin.
In a six-week, placebo-controlled study of 186 patients (aged 12-64 years) with allergic rhinitis and mild to moderate asthma, Cetirizine (Turbo Cough) 10 mg once daily improved rhinitis symptoms and did not alter pulmonary function. This study supports the safety of administering Cetirizine (Turbo Cough) to allergic rhinitis patients with mild to moderate asthma.
Clinical Trials
Turbo Cough (Cetirizine (Turbo Cough), Pseudoephedrine (Turbo Cough)) Tablets: Two multicenter, randomized, double-blind, placebo-controlled clinical trials (n = 1094 and n = 1000) comparing Turbo Cough (Cetirizine (Turbo Cough), Pseudoephedrine (Turbo Cough)) Tablets (Cetirizine (Turbo Cough) hydrochloride 5 mg and Pseudoephedrine (Turbo Cough) hydrochloride 120 mg) to active control and placebo for two weeks in patients 12 years and older with seasonal allergic rhinitis were conducted in the United States. In the two trials, 390 patients were aged 12 to 17 years. The primary efficacy measure in both trials was the mean change from baseline in the subject-rated Total Symptom Severity Complex (TSSC) score, which included the following symptoms: sneezing, runny nose, itchy nose, itchy eyes, watery eyes, postnasal drip, and nasal congestion. In both trials patients who received Turbo Cough (Cetirizine (Turbo Cough), Pseudoephedrine (Turbo Cough)) showed a significant reduction in the TSSC score compared to those who received placebo.
Zyrtec Tablets: Nine multicenter, randomized, double-blind, clinical trials comparing Cetirizine (Turbo Cough) 5 to 20 mg to placebo in patients 12 years and older with seasonal or perennial allergic rhinitis were conducted in the United States. Five of these showed significant reductions in symptoms of allergic rhinitis, 3 in seasonal allergic rhinitis (1 to 4 weeks in duration) and 2 in perennial allergic rhinitis for up to 8 weeks in duration. In general, the 10 mg dose was more effective than the 5 mg dose and the 20 mg dose gave no added effect. Some of these trials included pediatric patients aged 12 to 16 years.
References
- 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).
- DailyMed. "DEXTROMETHORPHAN HYDROBROMIDE: 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).
- 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).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
