Claridin AM Actions

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Consists of Ambroxol, Loratadine

Actions of Ambroxol (Claridin AM) in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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Pharmacology: Preclinically, Ambroxol (Claridin AM) hydrochloride, the active ingredient of Ambroxol (Claridin AM), has been shown to increase respiratory tract secretion. It enhances pulmonary surfactant production and stimulates ciliary activity. These actions result in improved mucus flow and transport (mucociliary clearance). Improvement of mucociliary clearance has been shown in clinical pharmacologic studies. Enhancement of fluid secretion and mucociliary clearance facilitates expectoration, and eases cough.

In patients suffering from COPD, long-term treatment (6 months) with Ambroxol (Claridin AM) (Ambroxol (Claridin AM) Retard Capsule 75 mg) resulted in a significant reduction of exacerbations that became evident after 2 months of treatment. Patients in the Ambroxol (Claridin AM) treatment group lost significantly fewer days through illness and had fewer days when they needed antibiotic therapy. Treatment with Ambroxol (Claridin AM) Retard also induced a statistically significant improvement of symptoms (difficulty of expectoration, cough, dyspnea, auscultatory signs) compared with placebo.

A local anaesthetic effect of Ambroxol (Claridin AM) hydrochloride has been observed in the rabbit eye model which may be explained by the sodium-channel blocking properties. It was shown in vitro that Ambroxol (Claridin AM) hydrochloride blocks cloned neuronal sodium channels; binding was reversible and concentration-dependent.

Cytokine release from blood but also tissue-bound mononuclear and polymorphonuclear cells was found to be significantly reduced by Ambroxol (Claridin AM) hydrochloride in vitro.

In clinical studies in patients with sore throat, pharyngeal pain and redness was significantly reduced.

Following the administration of Ambroxol (Claridin AM), antibiotic concentrations (amoxicilline, cefuroxime, erythromycin) in bronchopulmonary secretions and in the sputum are increased.

Pharmacokinetics: Absorption: Absorption of all immediate release oral forms of Ambroxol (Claridin AM) hydrochloride is rapid and complete, with dose linearity in the therapeutic range. Maximum plasma levels are reached within 1 to 2.5 hours following oral administration of the immediate-release formulation and after a median of 6.5 hours of the slow-release formulation. The absolute bioavailability after a 30 mg tablet was found to be 79%. The slow-release capsule showed a relative availability of 95% (dose-normalized) in comparison to a daily dose of 60 mg (30 mg twice daily) administered as immediate-release tablet.

Distribution: In the therapeutic range, plasma protein-binding was found to be approximately 90%. Distribution of Ambroxol (Claridin AM) hydrochloride from blood to tissue is rapid and pronounced, with the highest concentration of the active substance found in the lungs. The volume of distribution following oral administration was estimated to be 552 L.

Metabolism and Elimination: About 30% of an orally administered dose is eliminated via first-pass metabolism.

Studies in human liver microsomes have shown that CYP3A4 is responsible for the metabolism of Ambroxol (Claridin AM). Ambroxol (Claridin AM) hydrochloride is metabolized primarily in the liver by glucuronidation and some cleavage to dibromanthranilic acid (approximately 10% of dose) aside from some minor metabolites.

Ambroxol (Claridin AM) hydrochloride is eliminated with a terminal elimination half-life of approximately 10 hours. Total clearance is in the range of 660 mL/min, with renal clearance accounting for approximately 83% of the total clearance.

Special Populations: In patients with hepatic dysfunction, elimination of Ambroxol (Claridin AM) hydrochloride is reduced, resulting in approximately 1.3 to 2-fold higher plasma levels.

Due to the high therapeutic range of Ambroxol (Claridin AM) hydrochloride, dose adjustments are not necessary.

Others: Age and gender were not found to affect the pharmacokinetics of Ambroxol (Claridin AM) hydrochloride to a clinically relevant extent and thus there is no necessity for adjustment of dosage regimens.

Food was not found to influence the bioavailability of Ambroxol (Claridin AM) hydrochloride.

Ambroxol (Claridin AM) administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.
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Should be taken with food.

Ambroxol (Claridin AM) pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.

When Max Pidek Pharmaceuticals administered orally amoxicillin rapidly and completely absorbed from the gastrointestinal tract and is not destroyed in the acidic environment of the stomach. Cmax of amoxicillin in the blood plasma is reached after 1-2 h. When increasing doses of 2 times the concentration also increased by 2 times. In the presence of food in the stomach does not reduce the overall removals. Similar concentrations of amoxicillin reached in the blood when administered orally, IV and IM.

The binding of amoxicillin to plasma proteins is about 20%.

Widely distributed in tissues and body fluids. Reported high concentrations of amoxicillin in the liver.

T1/2 from the plasma is 1-1.5 h. About 60% of the dose adopted by mouth, is excreted unchanged in the urine by glomerular filtration and tubular secretion, with a dose of 250 mg of amoxicillin concentration in urine exceeds 300 micrograms / ml. A number of amoxicillin is determined in feces.

T1/2 for Newborns and the elderly can be longer.

In renal insufficiency T1/2 may be 7-20 hours.

In small quantities amoxicillin penetrates through BBB in inflammation of the pia mater.

amoxicillin is removed by hemodialysis.

Actions of Loratadine (Claridin AM) in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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Pharmacology: Loratadine (Claridin AM) like other antihistamines acts via competitive blocking of H1-histaminic receptors. Loratadine (Claridin AM) penetrates very poorly into CNS. Therefore, it is devoid of significant CNS depressant effects. Loratadine (Claridin AM) is highly selective antagonist of H1-histaminic receptors. Loratadine (Claridin AM) has very weak affinity for α-adrenoreceptors or acetylcholine receptors. In animal models, Loratadine (Claridin AM) has very high affinity for H1-histaminic receptors, which is greater than that of the terfenadine or astemizole. The antihistaminic effect persists for 18-24 hrs. In human subjects, Loratadine (Claridin AM) suppresses wheal response to intradermally injected histamine. This action starts within 1-2 hrs of oral administration and maximum inhibitory effect evident in 2-4 hrs. The magnitude and duration of effects are dependent upon Loratadine (Claridin AM) dose. On long-term administration, the drug retains its effectiveness without developing tachyphylaxis. In animal models, Loratadine (Claridin AM) has also shown anti-serotonin activity. It also suppresses mast cell mediator release.

In addition, Loratadine (Claridin AM) also possess anti-allergic activity which has been demonstrated in humans by skin prick and nasal challenge tests.

In human volunteers, Loratadine (Claridin AM) did not reduce psychomotor performance as measured by sleep latency, symbol copying, digit symbol substitution, dynamic visual activity test or driving performance. In addition, Loratadine (Claridin AM) does not potentiate the effects of centrally acting drugs eg, diazepam, ethanol and barbiturates.

Pharmacokinetics: Absorption: In humans, Loratadine (Claridin AM) is rapidly absorbed after oral administration. There is a linear relationship between Loratadine (Claridin AM) dose and both Cmax and AUC. The 10, 20 and 40 mg of Loratadine (Claridin AM) produce peak plasma concentrations of 5, 11, 28 mcg/L, respectively. Time to reach maximum concentration occurs between 1-1.5 hrs. After repeated dosing steady-state plasma concentrations occur by 5th day.

Metabolism: Loratadine (Claridin AM) is metabolized to descarboethoxyloratadine (DCL) which is pharmacologically active.

Distribution: Loratadine (Claridin AM) has extensive distribution in the body. The distribution t½ of Loratadine (Claridin AM) and DCL is 1.02 and 3.8 hrs, respectively.

Loratadine (Claridin AM) is 97-99% bound to plasma proteins whereas DCL is 73-76% bound to plasma proteins. Small amount of both Loratadine (Claridin AM) and DCL is secreted in breast milk, but the amount is minimal.

Elimination: Loratadine (Claridin AM) undergoes extensive biotransformation. The elimination t½ of Loratadine (Claridin AM) after single dose is 8-11 hrs and that of DCL is 17-24 hrs. After multiple dosing, elimination t½ of Loratadine (Claridin AM) is 4.4 hrs and that of DCL is 8.7 hrs.

Pharmacokinetics of Loratadine (Claridin AM) and that of DCL is not affected in patients with renal disease and in plasma patients on hemodialysis. In elderly patients too, disposition kinetics of Loratadine (Claridin AM) and DCL is not affected. In patients of alcoholic liver disease, the t½ of Loratadine (Claridin AM) and that of DCL are longer but still within the range observed in a population of normal subjects.

How should I take Loratadine (Claridin AM)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Loratadine (Claridin AM) is usually taken once per day. Follow your doctor's instructions.

Do not crush, chew, or break the regular Loratadine (Claridin AM) tablet. Swallow the pill whole.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

To take Loratadine (Claridin AM) orally disintegrating tablet (Loratadine (Claridin AM), Alavert):

Call your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat.

Loratadine (Claridin AM) administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.
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May be administered without regard to meals.

Dispersible tablet: Place in mouth and allow to dissolve. Swallow with or without water.

Loratadine (Claridin AM) pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.

Loratadine (Claridin AM) is a long acting second generation antihistamine that is similar in structure to cyproheptadine and azatadine. The pharmacology of Loratadine (Claridin AM) is similar to other antihistamines, but unlike other H1-blockers, loratidine is shown to exhibit competitive, specific, and selective antagonism of H1 receptors. The exact mechanism of this interaction is unknown, but disposition of the drug suggests that Loratadine (Claridin AM)'s prolonged antagonism of histamine may be due to the drug's slow dissociation from the receptor or the formation of the active metabolite, desloratadine. Loratadine (Claridin AM) does not penetrate the CNS effectively and has a low affinity for CNS H1-receptors.

References

  1. DailyMed. "LORATADINE; 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).
  2. NCIt. "Loratadine: 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).
  3. EPA DSStox. "Ambroxol: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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