How should I take Phensedyl COUGH?
Take Phensedyl COUGH exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Shake the liquid form of Phensedyl COUGH well before measuring a dose. To ensure that you get a correct dose, measure the suspension with a dose-measuring spoon, dropper, or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one. Do not mix the suspension with any other liquid before taking it. Mixing it with another liquid may change the way the medication is absorbed in the body. Phensedyl COUGH can be taken with food if stomach upset occurs. Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm. Codeine (Phensedyl COUGH) may be habit forming. Physical and/or psychological dependence can occur, and withdrawal effects are possible if the medication is stopped suddenly after prolonged or high-dose treatment. Do not stop taking Phensedyl COUGH suddenly without first talking to your doctor if you have been taking it continuously for more than 5 to 7 days. Your doctor may want to gradually reduce the dose. Store Phensedyl COUGH at room temperature away from moisture and heat.
Phensedyl COUGH administration
Administer with or without food. Shake extended-release suspension well before use. Administer with an accurate milliliter oral measuring device; do not use a household teaspoon to measure dose (overdosage may occur). Do not dilute with fluids or mix together with other drugs.
Phensedyl COUGH pharmacology
Pharmacodynamics
Codeine (Phensedyl COUGH)The precise mechanism of action of Codeine (Phensedyl COUGH) and other opiates is not known but it is believed to act in the medulla with depression of the cough center and to a lesser degree the respiratory center.
Chlorpheniramine (Phensedyl COUGH)
Chlorpheniramine (Phensedyl COUGH) is a propylamine derivative antihistamine (H1-receptor antagonist) of the alkylamine class that also possesses anticholinergic and sedative activity. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.
Pharmacokinetics
The bioavailability of Phensedyl COUGH has been assessed in single- and multiple-dose crossover studies in healthy adults. In a single-dose study, pharmacokinetic parameters for Phensedyl COUGH were evaluated in 20 fasting subjects and compared to two doses of an immediate-release reference solution containing 20 mg Codeine (Phensedyl COUGH) and 4 mg Chlorpheniramine (Phensedyl COUGH) maleate. In a separate study, single doses of Phensedyl COUGH were administered to 36 subjects, under both fed and fasted conditions. In a multi-dose study, the steady state pharmacokinetic parameters of Codeine (Phensedyl COUGH) and Chlorpheniramine (Phensedyl COUGH) were compared in 26 subjects who received Phensedyl COUGH administered twice daily and an immediate-release reference solution administered four times daily for one week.
Absorption
In two single dose studies with Phensedyl COUGH in fasting, healthy volunteers, Codeine (Phensedyl COUGH) mean (S.D.) peak plasma concentrations were 53.8 (13.4) ng/mL and 61.7 (18.5) ng/mL. Chlorpheniramine (Phensedyl COUGH) mean (S.D.) peak plasma concentrations were 7.9 (1.6) ng/mL and 7.4 (1.6) ng/mL. Peak plasma Codeine (Phensedyl COUGH) levels were reached approximately 2.5 to 3 hours following dosing. Peak plasma Chlorpheniramine (Phensedyl COUGH) levels were reached approximately 6.5 to 7 hours following dosing. Peak plasma concentrations of Codeine (Phensedyl COUGH) and Chlorpheniramine (Phensedyl COUGH) were reached approximately 2.7 and 9 hours respectively after dosing with the immediate-release reference solution.
Following multiple dosing with Phensedyl COUGH, Codeine (Phensedyl COUGH) mean (S.D.) peak plasma concentrations of 100.5 (26.8) ng/mL were reached at approximately 2 hours. Chlorpheniramine (Phensedyl COUGH) mean (S.D.) peak concentrations of 35.8 (10.0) ng/mL were reached approximately 3 hours following multiple dosing. Peak plasma concentrations of Codeine (Phensedyl COUGH) and Chlorpheniramine (Phensedyl COUGH) were reached approximately 1 and 3 hours respectively after dosing with the immediate-release reference solution.
Distribution
Codeine (Phensedyl COUGH) has been reported to have an apparent volume of distribution of approximately 3-6 L/kg, indicating extensive distribution of the drug into tissues. About 7-25% of Codeine (Phensedyl COUGH), reportedly, is bound to plasma proteins. Codeine (Phensedyl COUGH) passes the blood brain barrier and the placental barrier. Small amounts of Codeine (Phensedyl COUGH) and its metabolite, morphine, are transferred to human breast milk.
Chlorpheniramine (Phensedyl COUGH) is widely distributed throughout the tissues of the body, including the central nervous system. It reportedly has an apparent steady-state volume of distribution of approximately 3.2 L/kg in adults and children and is about 70% bound to plasma proteins. Chlorpheniramine (Phensedyl COUGH) and its metabolites likely cross the placental barrier and are excreted into human breast milk.
Food Effects
The bioavailability of Phensedyl COUGH Extended-Release Suspension was not affected when administered after a high fat meal. In a two-way crossover study, pharmacokinetic parameters were evaluated in 36 healthy subjects and no differences between fed and fasted groups were observed for either Cmax or AUC for either Codeine (Phensedyl COUGH) or Chlorpheniramine (Phensedyl COUGH). A statistically significant increase in Tmax for Chlorpheniramine (Phensedyl COUGH) from 6.3 hours to 9.1 hours was observed after a high fat meal; however this increase is unlikely to be clinically important.
Metabolism
Codeine (Phensedyl COUGH) is metabolized by conjugation with glucuronic acid to Codeine (Phensedyl COUGH)-6-glucuronide, and to a minor extent via O-demethylation to morphine (approximately 10% of administered dose) and via N-demethylation to norcodeine (approximately 10% of administered dose). Cytochrome P-450 2D6 is the major enzyme mediating O-demethylation of Codeine (Phensedyl COUGH) to morphine. Norcodeine formation is predominately catalyzed by cytochrome P-450 3A4 mediated N-demethylation. Norcodeine and morphine are further metabolized by conjugation with glucuronic acid. These metabolites and their conjugates are pharmacologically active. Whether Codeine (Phensedyl COUGH)-6-glucuronide has pharmacological activity is unknown, but activity similar to Codeine (Phensedyl COUGH) itself is expected.
Chlorpheniramine (Phensedyl COUGH) is rapidly and extensively metabolized via demethylation in the liver, forming mono- and didesmethyl derivatives. Oxidative metabolism of Chlorpheniramine (Phensedyl COUGH) is catalyzed by cytochrome P-450 2D6.
Elimination
Approximately 90% of the total dose of Codeine (Phensedyl COUGH) is excreted through the kidneys, of which approximately 10% is unchanged Codeine (Phensedyl COUGH).
Plasma half-lives of Codeine (Phensedyl COUGH) have been reported to be approximately 3 hours.
Chlorpheniramine (Phensedyl COUGH) and its metabolites are primarily excreted through the kidneys, with large individual variation. Urinary excretion depends on urine pH and flow rate.
Plasma half-lives for Chlorpheniramine (Phensedyl COUGH) have been reported to range from approximately 2 to 43 hours in adults and 5 to 16 hours in children.
References
- 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).
- DailyMed. "CODEINE 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).
- NCIt. "Codeine Phosphate: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Phensedyl COUGH are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Phensedyl COUGH. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
