Quinine Capsules Actions

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Actions of Quinine Capsules 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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Description: Quinine Capsules is a cinchona alkaloid and a 4-methanolquinoline. It rapidly acts on blood schizontocide by interfering w/ lysosomal function or nucleic acid synthesis in the Plasmodia spp. It has no activity against exoerythrocytic forms.

Pharmacokinetics:

Absorption: Rapid and almost complete from the GI tract.

Oral bioavailability: 76-88%. Time to peak plasma concentration: Approx 1-3 hr.

Distribution: Widely distributed; crosses the placenta; enters breast milk. Volume of distribution: 2.5-7.1 L/kg. Plasma protein binding: Approx 70%.

Metabolism: Extensively hepatic via CYP450 isoenzymes into 3-hydroxyquinine and other metabolites.

Excretion: Via urine (approx 20% as unchanged drug). Elimination half-life: Approx 11 hr.

How should I take Quinine Capsules?

Take Quinine Capsules only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.

Quinine Capsules comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Quinine Capsules may be given together with one or more medicines for malaria. Make sure you take all of the medicines your doctor ordered. If you have any questions about this, talk to your doctor.

Take Quinine Capsules with food to lessen stomach upset, unless otherwise directed by your doctor. If you are taking Quinine Capsules at bedtime, take it with a snack, water, milk, or other beverage.

To help clear up the malaria completely, keep taking Quinine Capsules for the full time of treatment, even if you begin to feel better after a few days. If you stop taking Quinine Capsules too soon, your symptoms may return. Do not miss any doses.

Dosing

The dose of Quinine Capsules will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Quinine Capsules. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of Quinine Capsules, 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.

If it has been more than 4 hours since you missed a dose, skip the missed dose and take your next dose at the regular time.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Quinine Capsules 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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Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take with food if Quinine Capsules upsets your stomach.

Quinine Capsules is usually taken for 7 days. Call your doctor if your malaria symptoms do not improve after 2 days of taking Quinine Capsules, or if your symptoms return after you have finished the medication. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

Take this medication for the full prescribed length of time. Your symptoms may get better before your condition is completely cleared. If you stop using the medication early for any reason, talk to your doctor about other forms of malaria prevention.

If you need surgery, tell the surgeon ahead of time that you are using Quinine Capsules. You may need to stop using the medicine for a short time. This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Quinine Capsules.

Store at room temperature away from moisture and heat.

Quinine Capsules 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.
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Mechanism Of Action

Quinine Capsules is an antimalarial agent.

Pharmacodynamics

QTc interval prolongation was studied in a double-blind, multiple dose, placebo-and positive-controlled crossover study in young (N=13, 20 to 39 years) and elderly (N=13, 65 to 78 years) subjects. After 7 days of dosing with Quinine Capsules 648 mg three times daily, the maximum mean (95% upper confidence bound) differences in QTcI from placebo after baseline correction was 27.7 (32.2) ms.

Prolongation of the PR and QRS interval was also noted in subjects receiving Quinine Capsules. The maximum mean (95% upper confidence bound) difference in PR from placebo after baseline-correction was 14.5 (18.0) ms. The maximum mean (95% upper confidence bound) difference in QRS from placebo after baseline-correction was 11.5 (13.3) ms..

Pharmacokinetics

Absorption

The oral bioavailability of Quinine Capsules is 76 to 88% in healthy adults. Quinine Capsules exposure is higher in patients with malaria than in healthy subjects. After a single oral dose of Quinine Capsules sulfate, the mean Quinine Capsules Tmax was longer, and mean AUC and Cmax were higher in patients with uncomplicated P. falciparum malaria than in healthy subjects, as shown in Table 1 below.

TABLE 1 : Pharmacokinetic Parameters of Quinine Capsules in Healthy Subjects and Patients with Uncomplicated P. falciparum Malaria after a Single Doseage 1.5 to 12 years

Geriatric Patients: Following a single oral dose of 600 mg Quinine Capsules sulfate, the mean AUC was about 38% higher in 8 healthy elderly subjects (65 to 78 years old) than in 12 younger subjects (20 to 35 years old). The mean Tmax and Cmax were similar in elderly and younger subjects after a single oral dose of Quinine Capsules sulfate 600 mg. The mean oral clearance of Quinine Capsules was significantly decreased, and the mean elimination half-life was significantly increased in elderly subjects compared with younger subjects (0.06 vs. 0.08 L/h/kg, and 18.4 hours vs. 10.5 hours, respectively). Although there was no significant difference in the renal clearance of Quinine Capsules between the two age groups, elderly subjects excreted a larger proportion of the dose in urine as unchanged drug than younger subjects (16.6% vs. 11.2%).

After a single 648 mg dose or at steady state, following Quinine Capsules sulfate 648 mg given three times daily for 7 days, no difference in the rate and extent of absorption or clearance of Quinine Capsules was seen between 13 elderly subjects (65 to 78 years old) and 14 young subjects (20 to 39 years old). The mean elimination half-life was 20% longer in the elderly subjects (24.0 hours) than in younger subjects (20.0 hours). The steady state Cmax (±SD) and AUC0-8 (±SD) for healthy volunteers are 6.8 ± 1.24 mcg/mL and 48.8 ± 9.15 mcg*h/mL, respectively, following 7 days of oral Quinine Capsules sulfate 648 mg three times daily. The steady state pharmacokinetic parameters in healthy elderly subjects were similar to the pharmacokinetic parameters in healthy young subjects.

Renal Impairment: Following a single oral 600 mg dose of Quinine Capsules sulfate in otherwise healthy subjects with severe chronic renal failure not receiving any form of dialysis (mean serum creatinine = 9.6 mg/dL), the median AUC was higher by 195% and the median Cmax was higher by 79% than in subjects with normal renal function (mean serum creatinine = 1 mg/dL). The mean plasma half-life in subjects with severe chronic renal impairment was prolonged to 26 hours compared to 9.7 hours in the healthy controls. Computer assisted modeling and simulation indicates that in patients with malaria and severe chronic renal failure, a dosage regimen consisting of one loading dose of 648 mg Quinine Capsules followed 12 hours later by a maintenance dosing regimen of 324 mg every 12 hours will provide adequate systemic exposure to Quinine Capsules. The effects of mild and moderate renal impairment on the pharmacokinetics and safety of Quinine Capsules sulfate are not known.

Negligible to minimal amounts of circulating Quinine Capsules in the blood are removed by hemodialysis or hemofiltration. In subjects with chronic renal failure (CRF) on hemodialysis, only about 6.5% of Quinine Capsules is removed in 1 hour. Plasma Quinine Capsules concentrations do not change during or shortly after hemofiltration in subjects with CRF.

Hepatic Impairment: In otherwise healthy subjects with mild hepatic impairment (Child-Pugh A; N=10), who received a single 500 mg dose of Quinine Capsules sulfate, there was no significant difference in Quinine Capsules pharmacokinetic parameters or exposure to the primary metabolite, 3-hydroxyquinine as compared to healthy controls (N=10).

In otherwise healthy subjects with moderate hepatic impairment (Child-Pugh B; N=9) who received a single oral 600 mg dose of Quinine Capsules sulfate, the mean AUC increased by 55% without a significant change in mean Cmax, as compared to healthy volunteer controls (N=6). In subjects with hepatitis, the absorption of Quinine Capsules was prolonged, the elimination half-life was increased, the apparent volume of distribution was higher, but there was no significant difference in weight-adjusted clearance. Therefore, in patients with mild to moderate hepatic impairment, dosage adjustment is not needed, but patients should be monitored closely for adverse effects of Quinine Capsules.

In subjects with severe hepatic impairment (Child-Pugh C; N=10), Quinine Capsules oral clearance (CL/F) was reduced as was formation of the primary 3-hydroxyquinine metabolite. Volume of distribution (Vd/F) was higher and the plasma elimination half-life was increased. Therefore, Quinine Capsules is not indicated in this population and alternate therapy should be administered.

Microbiology

Mechanism Of Action

Quinine Capsules inhibits nucleic acid synthesis, protein synthesis, and glycolysis in Plasmodium falciparum and can bind with hemazoin in parasitized erythrocytes. However, the precise mechanism of the antimalarial activity of Quinine Capsules sulfate is not completely understood.

Activity In Vitro and In Vivo

Quinine Capsules sulfate acts primarily on the blood schizont form of P. falciparum. It is not gametocidal and has little effect on the sporozoite or pre-erythrocytic forms.

Drug Resistance

Strains of P. falciparum with decreased susceptibility to Quinine Capsules can be selected in vivo. P. falciparum malaria that is clinically resistant to Quinine Capsules has been reported in some areas of South America, Southeast Asia, and Bangladesh.

Clinical Studies

Quinine Capsules has been used worldwide for hundreds of years in the treatment of malaria. Thorough searches of the published literature identified over 1300 references to the treatment of malaria with Quinine Capsules, and from these, 21 randomized, active-controlled studies were identified which evaluated oral Quinine Capsules monotherapy or combination therapy for treatment of uncomplicated P. falciparum malaria. Over 2900 patients from malaria-endemic areas were enrolled in these studies, and more than 1400 patients received oral Quinine Capsules. The following conclusions were drawn from review of these studies:

In areas where multi-drug resistance of P. falciparum is increasing, such as Southeast Asia, cure rates with 7 days of oral Quinine Capsules monotherapy were at least 80%; while cure rates for 7 days of oral Quinine Capsules combined with an antimicrobial agent (tetracycline or clindamycin) were greater than 90%. In areas where multi-drug resistance of the parasite was not as widespread, cure rates with 7 days of Quinine Capsules monotherapy ranged from 86 to 100%. Cure was defined as initial clearing of parasitemia within 7 days without recrudescence by day 28 after treatment initiation. P. falciparum malaria that is clinically resistant to Quinine Capsules has been reported in some areas of South America, Southeast Asia, and Bangladesh, and Quinine Capsules may not be as effective in those areas.

Completion of a 7-day oral Quinine Capsules treatment regimen may be limited by drug intolerance, and shorter courses (3 days) of Quinine Capsules combination therapy have been used. However, the published data from randomized, controlled clinical trials for shorter regimens of oral Quinine Capsules in conjunction with tetracycline, doxycycline, or clindamycin for treatment of uncomplicated P. falciparum malaria is limited, and these shorter course combination regimens may not be as effective as the longer regimens.



References

  1. DailyMed. "QUININE 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. "Quinine: 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. "Quinine: 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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