How should I take Zodryl AC 35?
Take Zodryl AC 35 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 Zodryl AC 35 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. Zodryl AC 35 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 (Zodryl AC 35) 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 Zodryl AC 35 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 Zodryl AC 35 at room temperature away from moisture and heat.
Zodryl AC 35 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.
Zodryl AC 35 pharmacology
Pharmacodynamics
Codeine (Zodryl AC 35)The precise mechanism of action of Codeine (Zodryl AC 35) 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 (Zodryl AC 35)
Chlorpheniramine (Zodryl AC 35) 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 Zodryl AC 35 has been assessed in single- and multiple-dose crossover studies in healthy adults. In a single-dose study, pharmacokinetic parameters for Zodryl AC 35 were evaluated in 20 fasting subjects and compared to two doses of an immediate-release reference solution containing 20 mg Codeine (Zodryl AC 35) and 4 mg Chlorpheniramine (Zodryl AC 35) maleate. In a separate study, single doses of Zodryl AC 35 were administered to 36 subjects, under both fed and fasted conditions. In a multi-dose study, the steady state pharmacokinetic parameters of Codeine (Zodryl AC 35) and Chlorpheniramine (Zodryl AC 35) were compared in 26 subjects who received Zodryl AC 35 administered twice daily and an immediate-release reference solution administered four times daily for one week.
Absorption
In two single dose studies with Zodryl AC 35 in fasting, healthy volunteers, Codeine (Zodryl AC 35) mean (S.D.) peak plasma concentrations were 53.8 (13.4) ng/mL and 61.7 (18.5) ng/mL. Chlorpheniramine (Zodryl AC 35) mean (S.D.) peak plasma concentrations were 7.9 (1.6) ng/mL and 7.4 (1.6) ng/mL. Peak plasma Codeine (Zodryl AC 35) levels were reached approximately 2.5 to 3 hours following dosing. Peak plasma Chlorpheniramine (Zodryl AC 35) levels were reached approximately 6.5 to 7 hours following dosing. Peak plasma concentrations of Codeine (Zodryl AC 35) and Chlorpheniramine (Zodryl AC 35) were reached approximately 2.7 and 9 hours respectively after dosing with the immediate-release reference solution.
Following multiple dosing with Zodryl AC 35, Codeine (Zodryl AC 35) mean (S.D.) peak plasma concentrations of 100.5 (26.8) ng/mL were reached at approximately 2 hours. Chlorpheniramine (Zodryl AC 35) 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 (Zodryl AC 35) and Chlorpheniramine (Zodryl AC 35) were reached approximately 1 and 3 hours respectively after dosing with the immediate-release reference solution.
Distribution
Codeine (Zodryl AC 35) 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 (Zodryl AC 35), reportedly, is bound to plasma proteins. Codeine (Zodryl AC 35) passes the blood brain barrier and the placental barrier. Small amounts of Codeine (Zodryl AC 35) and its metabolite, morphine, are transferred to human breast milk.
Chlorpheniramine (Zodryl AC 35) 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 (Zodryl AC 35) and its metabolites likely cross the placental barrier and are excreted into human breast milk.
Food Effects
The bioavailability of Zodryl AC 35 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 (Zodryl AC 35) or Chlorpheniramine (Zodryl AC 35). A statistically significant increase in Tmax for Chlorpheniramine (Zodryl AC 35) 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 (Zodryl AC 35) is metabolized by conjugation with glucuronic acid to Codeine (Zodryl AC 35)-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 (Zodryl AC 35) 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 (Zodryl AC 35)-6-glucuronide has pharmacological activity is unknown, but activity similar to Codeine (Zodryl AC 35) itself is expected.
Chlorpheniramine (Zodryl AC 35) is rapidly and extensively metabolized via demethylation in the liver, forming mono- and didesmethyl derivatives. Oxidative metabolism of Chlorpheniramine (Zodryl AC 35) is catalyzed by cytochrome P-450 2D6.
Elimination
Approximately 90% of the total dose of Codeine (Zodryl AC 35) is excreted through the kidneys, of which approximately 10% is unchanged Codeine (Zodryl AC 35).
Plasma half-lives of Codeine (Zodryl AC 35) have been reported to be approximately 3 hours.
Chlorpheniramine (Zodryl AC 35) 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 (Zodryl AC 35) 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 Zodryl AC 35 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 Zodryl AC 35. 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
