Actions of Choline Salicylate (Dologel) 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: Choline Salicylate (Dologel) alleviates pain by inhibition of prostaglandin synthesis and reduce fever by acting on the hypothalamus heat-regulating center. It also blocks the generation of impulses.
Onset: 1-2 hr.
How should I take Choline Salicylate (Dologel)?
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.
This section provides information on the proper use of a number of products that contain salicylate. It may not be specific to Choline Salicylate (Dologel). Please read with care.
Take this medicine after meals or with food (except for enteric-coated capsules or tablets and aspirin suppositories) to lessen stomach irritation.
Take tablet or capsule forms of this medicine with a full glass (8 ounces) of water. Also, do not lie down for about 15 to 30 minutes after swallowing the medicine. This helps to prevent irritation that may lead to trouble in swallowing.
Do not use any product that contains aspirin if it has a strong, vinegar-like odor. This odor means the medicine is breaking down. If you have any questions about this, check with your health care professional.
If you are to take any medicine that contains aspirin within 7 days after having your tonsils removed, a tooth pulled, or other dental or mouth surgery, be sure to swallow the aspirin whole. Do not chew aspirin during this time.
Do not place any medicine that contains aspirin directly on a tooth or gum surface. This may cause a burn.
There are several different forms of aspirin or buffered aspirin tablets. If you are using:
chewable aspirin tablets, they may be chewed, dissolved in liquid, crushed, or swallowed whole.
delayed-release (enteric-coated) aspirin tablets, they must be swallowed whole. Do not crush them or break them up before taking.
extended-release (long-acting) aspirin tablets, check with your pharmacist as to how they should be taken. Some may be broken up (but must not be crushed) before swallowing if you cannot swallow them whole. Others should not be broken up and must be swallowed whole.
To use aspirin suppositories:
If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.
To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.
To take Choline Salicylate (Dologel) and magnesium salicylates (e.g., Trilisate) oral solution:
The liquid may be mixed with fruit juice just before taking.
Drink a full glass (8 ounces) of water after taking the medicine.
To take enteric-coated sodium salicylate tablets:
The tablets must be swallowed whole. Do not crush them or break them up before taking.
Unless otherwise directed by your medical doctor or dentist:
Do not take more of this medicine than recommended on the label, to lessen the chance of side effects.
Children up to 12 years of age should not take this medicine more than 5 times a day.
When used for arthritis (rheumatism), this medicine must be taken regularly as ordered by your doctor in order for it to help you. Up to 2 to 3 weeks or longer may pass before you feel the full effects of this medicine.
Dosing
The dose medicines in this class 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 these medicines. 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.
For aspirin
For oral dosage forms (short-acting tablets, chewable tablets, and delayed-release [enteric-coated] tablets):
For pain or fever:
Adults and teenagers—325 to 500 milligrams (mg) every three or four hours, 650 mg every four to six hours, or 1000 mg every six hours as needed.
Children 11 to 12 years of age—320 to 480 mg every four hours as needed.
Children 9 to 11 years of age—320 to 400 mg every four hours as needed.
Children 6 to 9 years of age—320 to 325 mg every four hours as needed.
Children 4 to 6 years of age—240 mg every four hours as needed.
Children 2 to 4 years of age—160 mg every four hours as needed.
Children up to 2 years of age—Dose must be determined by your doctor.
For arthritis:
Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.
Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.
For preventing a heart attack, stroke, or other problems caused by blood clots:
Adults—Most people will take 81, 162.5, or 325 mg a day or 325 mg every other day. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.
Children—Use and dose must be determined by your doctor.
For oral dosage form (chewing gum):
For pain:
Adults and teenagers—2 tablets every four hours as needed.
Children 6 to 12 years of age—1 or 2 tablets (227 mg each) up to four times a day.
Children 3 to 6 years of age—1 tablet (227 mg) up to three times a day.
Children up to 3 years of age—Dose must be determined by your doctor.
For long-acting oral dosage form (extended-release tablets):
For pain:
Adults and teenagers—1 or 2 tablets twice a day.
Children—The long-acting aspirin tablets are too strong for use in children.
For arthritis:
Adults and teenagers—1 or 2 tablets twice a day, at first. Your doctor will then adjust your dose as needed.
Children—The long-acting aspirin tablets are too strong for use in children.
For rectal dosage form (suppositories):
For pain or fever:
Adults and teenagers—325 to 650 mg every four hours as needed.
Children 11 to 12 years of age—325 to 480 mg every four hours as needed.
Children 9 to 11 years of age—325 to 400 mg every four hours as needed.
Children 6 to 9 years of age—325 mg every four hours as needed.
Children 4 to 6 years of age—240 mg every four hours as needed.
Children 2 to 4 years of age—160 mg every four hours as needed.
Children up to 2 years of age—Dose must be determined by your doctor.
For arthritis:
Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.
Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.
For aspirin and caffeine
For oral dosage forms (capsule):
For pain or fever:
Adults and teenagers—325 to 500 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.
Children 9 to 12 years of age—325 to 400 mg every four hours as needed.
Children 6 to 9 years of age—325 mg every four hours as needed.
Children up to 6 years of age—Aspirin and caffeine capsules are too strong for use in children up to 6 years of age
For preventing a heart attack, stroke, or other problems caused by blood clots:
Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.
Children—Use and dose must be determined by your doctor.
For oral dosage form (tablets):
For pain or fever:
Adults and teenagers—325 to 500 mg of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.
Children 9 to 12 years of age—325 to 400 mg every four hours as needed.
Children up to 9 years of age—Aspirin and caffeine tablets are too strong for use in children up to 9 years of age.
For arthritis:
Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.
Children—A total of 80 to 100 mg per kg (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.
For preventing a heart attack, stroke, or other problems caused by blood clots:
Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.
Children—Use and dose must be determined by your doctor.
For buffered aspirin
For oral dosage forms (tablets):
For pain or fever:
Adults and teenagers—325 to 500 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.
Children 11 to 12 years of age—One or one and one-half 325-mg tablets every four hours as needed.
Children 9 to 11 years of age—One or one and one-fourth 325-mg tablets every four hours as needed.
Children 6 to 9 years of age—One 325-mg tablet every four hours as needed.
Children 4 to 6 years of age—Three-fourths of a 325-mg tablet every four hours as needed.
Children 2 to 4 years of age—One-half of a 325-mg tablet every four hours as needed.
Children up to 2 years of age—Dose must be determined by your doctor.
For arthritis:
Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.
Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.
For preventing a heart attack, stroke, or other problems caused by blood clots:
Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.
Children—Use and dose must be determined by your doctor.
For buffered aspirin and caffeine
For oral dosage form (tablets):
For pain or fever:
Adults and teenagers—325 or 421 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 842 mg of aspirin every six hours as needed.
Children 11 to 12 years of age—One or one and one-half 325-mg tablets, or one 421-mg tablet, every four hours as needed.
Children 9 to 11 years of age—One or one and one-fourth 325-mg tablets every four hours as needed.
Children 6 to 9 years of age—One 325-mg or 421-mg tablet every four hours as needed.
Children 4 to 6 years of age—Three-fourths of a 325-mg tablet every four hours as needed.
Children 2 to 4 years of age—One-half of a 325-mg tablet every four hours as needed.
Children up to 2 years of age—Dose must be determined by your doctor.
For arthritis:
Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.
Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.
For preventing a heart attack, stroke, or other problems caused by blood clots:
Adults—162.5 or 325 mg (one-half or one 325-mg tablet) a day or 325 mg every other day. People who need smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.
Children—Use and dose must be determined by your doctor.
For Choline Salicylate (Dologel)
For oral dosage form (oral solution):
For pain or fever:
Adults and teenagers—One-half or three-fourths of a teaspoonful every three hours, one-half or one teaspoonful every four hours, or one or one and one-half teaspoonfuls every six hours as needed.
Children 11 to 12 years of age—2.5 to 3.75 mL (one-half to three-fourths of a teaspoonful) every four hours as needed. This amount should be measured by a special measuring spoon.
Children 6 to 11 years of age—2.5 mL (one-half of a teaspoonful) every four hours as needed. This amount should be measured by a special measuring spoon.
Children 4 to 6 years of age—1.66 mL every four hours as needed. This amount should be measured by a special dropper or measuring spoon.
Children 2 to 4 years of age—1.25 milliliters (mL) (one-fourth of a teaspoonful) every four hours as needed. This amount should be measured by a special dropper or measuring spoon.
Children up to 2 years of age—Dose must be determined by your doctor.
For arthritis:
Adults—A total of five and one-half to eight teaspoonfuls a day, divided into several smaller doses.
Children—A total of 0.6 to 0.7 mL per kilogram (kg) (0.25 to 0.28 mL per pound) of body weight a day, divided into several smaller doses.
For Choline Salicylate (Dologel) and magnesium salicylates
For oral dosage forms (oral solution or tablets):
For pain or fever:
Adults and teenagers—A total of 2000 to 3000 milligrams (mg) a day, divided into two or three doses.
Children weighing more than 37 kg (90 pounds or more)—2200 mg a day, divided into two doses.
Children weighing up to 37 kilograms (kg) (about 89 pounds)—A total of 50 mg per kg (20 mg per pound) of body weight a day, divided into two doses.
For magnesium salicylate
For oral dosage form (tablets):
For pain:
Adults and teenagers—2 regular-strength tablets every four hours, up to a maximum of 12 tablets a day, or 2 extra-strength tablets every eight hours, up to a maximum of 8 tablets a day.
Children—Dose must be determined by your doctor.
For salsalate
For oral dosage forms (capsules or tablets):
For arthritis:
Adults and teenagers—500 to 1000 milligrams (mg) two or three times a day, to start. Your doctor will then adjust your dose as needed.
Children—Dose must be determined by your doctor.
For sodium salicylate
For oral dosage forms (tablets or delayed-release [enteric-coated] tablets):
For pain or fever:
Adults and teenagers—325 or 650 milligrams (mg) every four hours as needed.
Children 6 years of age and older—325 mg every four hours as needed.
Children up to 6 years of age—This medicine is too strong for use in children younger than 6 years of age.
For arthritis:
Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.
Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.
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.
Choline Salicylate (Dologel) 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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This compound is needed for good nerve conduction throughout the CNS (central nervous system) as it is a precursor to acetylcholine (ACh). Choline Salicylate (Dologel) is also needed for gallbladder regulation, liver function and lecithin (a key lipid) formation. Choline Salicylate (Dologel) also aids in fat and cholesterol metabolism and prevents excessive fat build up in the liver. Choline Salicylate (Dologel) has been used to mitigate the effects of Parkinsonism and tardive dyskinesia. Choline Salicylate (Dologel) deficiencies may result in excessive build-up of fat in the liver, high blood pressure, gastric ulcers, kidney and liver dysfunction and stunted growth.
Actions of Lidocaine (Dologel) 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.
Pharmacology: Pharmacodynamics: Mechanism of Action: Lidocaine (Dologel) when applied topically in the form of the plaster has been shown in studies to produce a local analgesic effect. The mechanism by which this occurs is due to stabilisation of neuronal membranes, which is thought to cause down regulation of sodium channels resulting in pain reduction.
Clinical Efficacy: Pain management in post-herpetic neuralgia (PHN) is difficult. There is evidence of efficacy with Lidocaine (Dologel) in the symptomatic relief from the allodynic component of PHN in some cases.
Efficacy of Lidocaine (Dologel) has been shown in PHN studies. Other models of neuropathic pain have not been studied.
There were 2 main controlled studies carried out to assess the efficacy of the Lidocaine (Dologel) 5% medicated plaster.
In the 1st study, patients were recruited from a population who were already considered to respond to Lidocaine (Dologel). It was a crossover design of 14 days treatment with Lidocaine (Dologel) 5% medicated plaster followed by placebo or vice versa. The primary endpoint was the time to exit, where patients withdrew because their pain relief was 2 points lower than their normal response on a 6-point scale (ranging from worse to complete relief). There were 32 patients, of whom 30 completed. The median time to exit for placebo was 4 days and for active was 14 days (p value <0.001); none of those on active discontinued during the 2-week treatment period.
In the 2nd study, 265 patients with PHN were recruited and allocated 8 weeks of open label active treatment with Lidocaine (Dologel) 5% medicated plaster. In this uncontrolled setting, approximately 50% of patients responded to treatment as measured by 2 points lower than their normal response on a 6-point scale (ranging from worse to complete relief). A total of 71 patients were randomised to receive either placebo or Lidocaine (Dologel) 5% medicated plaster given for 2-14 days. The primary endpoint was defined as lack of efficacy on 2 consecutive days leading to withdrawal of treatment. There were 9/36 patients on active and 16/35 patients on placebo who withdrew because of lack of treatment benefit.
Post-hoc analyses of the 2nd study showed that the initial response was independent of the duration of preexisting PHN. However, the notion that patients with longer duration of PHN (>12 months) do benefit more from active treatment is supported by the finding that this group of patients was more likely to drop out due to lack of efficacy when switched to placebo during the double-blind withdrawal part of this study.
Pharmacokinetics: Absorption: When Lidocaine (Dologel) 5% medicated plaster is used according to the maximum recommended dose (3 plasters applied simultaneously for 12 hr) about 3±2% of the total applied Lidocaine (Dologel) dose is systemically available and similar for single and multiple administrations.
A population kinetics analysis of the clinical efficacy studies in patients suffering from PHN revealed a mean maximum concentration for Lidocaine (Dologel) of 45 ng/mL after application of 3 plasters simultaneously 12 hr/day after repeated application for up to 1 year. This concentration is in accordance with the observation in pharmacokinetic studies in PHN patients (52 ng/mL) and in healthy volunteers (85 and 125 ng/mL).
For Lidocaine (Dologel) and its metabolites monoethylglycinexylidide (MEGX) and glycinexylidide (GX) and 2,6-xylidine, no tendency for accumulation was found, steady state concentrations were reached within the 1st 4 days.
The population kinetic analysis indicated that when increasing the number from 1-3 plasters worn simultaneously, the systemic exposure increased less than proportionally to the number of used plasters.
Distribution: After IV administration of Lidocaine (Dologel) to healthy volunteers, the volume of distribution was found to be 1.3±0.4 L/kg (mean ± S.D., n=15). The Lidocaine (Dologel) distribution volume showed no age-dependency, it is decreased in patients with congestive heart failure and increased in patients with liver disease. At plasma concentrations produced by application of the plaster approximately 70% of Lidocaine (Dologel) is bound to plasma proteins. Lidocaine (Dologel) crosses the placenta and blood brain barriers presumably by passive diffusion.
Biotransformation: Lidocaine (Dologel) is metabolised rapidly in the liver to a number of metabolites. The primary metabolic route for Lidocaine (Dologel) is N-dealkylation to MEGX, GX both of which are less active than Lidocaine (Dologel) and available in low concentrations. These are hydrolyzed to 2,6-xylidine, which is converted to conjugated 4-hydroxy-2,6-xylidine.
The metabolite, 2,6-xylidine, has unknown pharmacological activity but shows carcinogenic potential in rats. A population kinetics analysis revealed a mean maximum concentration for 2,6-xylidine of 9 ng/mL after repeated daily applications for up to 1 year This finding is confirmed by a phase I pharmacokinetic study. Data on Lidocaine (Dologel) metabolism in the skin are not available.
Elimination: Lidocaine (Dologel) and its metabolites are excreted by the kidneys. More than 85% of the dose is found in the urine in the form of metabolites or active substance. Less than 10% of the Lidocaine (Dologel) dose is excreted unchanged. The main metabolite in urine is a conjugate of 4-hydroxy-2,6-xylidine, accounting for about 70-80% of the dose excreted in the urine. 2,6-xylidine is excreted in the urine in man at a concentration of <1% of the dose. The elimination t½ of Lidocaine (Dologel) after plaster application in healthy volunteers is 7.6 hrs. The excretion of Lidocaine (Dologel) and its metabolites may be delayed in cardiac, renal or hepatic insufficiency.
Toxicology: Preclinical Safety Data: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
In toxicological studies described in the literature using systemic administration of Lidocaine (Dologel), cardiovascular effects (tachycardia or bradycardia, decreases in cardiac output and blood pressure, cardiac arrest) and central nervous system effects (convulsion, coma, respiratory arrest) were observed at exposures considered sufficiently in excess of the maximum human exposure following treatment with Lidocaine (Dologel). This indicates that these effects have little relevance to clinical use.
Lidocaine (Dologel) hydrochloride has shown no genotoxicity when investigated in vitro or in vivo. Its hydrolysis product and metabolite, 2,6-xylidine, showed mixed genotoxic activity in several assays particularly after metabolic activation.
Carcinogenicity studies have not been performed with Lidocaine (Dologel). Studies performed with the metabolite 2,6-xylidine mixed in the diet of male and female rats resulted in treatment-related cytotoxicity and hyperplasia of the nasal olfactory epithelium and carcinomas and adenomas in the nasal cavity were observed. Tumorigenic changes were also found in the liver and subcutis. Because the risk to humans is unclear, long-term treatment with high doses of Lidocaine (Dologel) should be avoided.
Lidocaine (Dologel) had no effect on general reproductive performance or female fertility in rats at plasma concentrations up to 130-fold those observed in patients. No adverse effects were seen in an embryofoetal/teratogenicity study in rats at plasma concentrations >200-fold that observed in humans.
Animal studies are incomplete with respect to effects on pregnancy, embryofoetal development, parturition or postnatal development.
How should I take Lidocaine (Dologel)?
Use Lidocaine (Dologel) exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. Lidocaine (Dologel) may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.
Lidocaine (Dologel) should only be used for problems being treated by your doctor. Check with your doctor before using it for other problems, especially if you think that an infection may be present. Lidocaine (Dologel) should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.
If you are using the topical jelly or ointment:
A nurse or other trained health care professional may give you Lidocaine (Dologel) before having a medical procedure.
Wash your hands with soap and water before and after using Lidocaine (Dologel).
Unless otherwise directed by your doctor, do not apply Lidocaine (Dologel) to open wounds, burns, or broken or inflamed skin.
Be careful not to get any of the ointment in your eyes, because it can cause severe eye irritation. If any of the medicine does get in the eyes, wash the eyes with water for at least 15 minutes and check with your doctor right away.
If you are using the viscous topical solution:
Wash your hands with soap and water before and after using Lidocaine (Dologel).
Use of an accurate measuring device is recommended, to avoid using more than the prescribed amount of medicine.
If you are using Lidocaine (Dologel) in the mouth, swish the solution around in the mouth and spit it out.
If you are using Lidocaine (Dologel) in the throat, gargle the undiluted solution. You may also swallow the solution.
If you are using the skin patch:
Use Lidocaine (Dologel) exactly as directed by your doctor. It will work only if applied correctly.
Lidocaine (Dologel) should only be used on the skin. Do not get it in your eyes, nose, or mouth. If it does get on these areas, rinse it off with water or saline right away.
Wash your hands with soap and water before and after applying a patch.
Keep the patch in its protective envelope until you are ready to put it on. You may cut the patch into smaller sizes with scissors after removing the patch release liner.
Apply the patch to a clean, dry, intact skin. Choose an area with little or no hair and free of scars, cuts, or irritation. Avoid putting the patch on areas where it could be rubbed off by tight clothing.
Put on a new patch if the old one has fallen off and cannot be reapplied.
Do not use the patch when you take a bath, shower, or swim. Always keep the patch dry.
Dosing
The dose of Lidocaine (Dologel) 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 Lidocaine (Dologel). 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.
For topical dosage form (ointment):
For pain and itching caused by minor skin conditions:
Adults—Apply to the affected area three or four times a day. The largest amount of ointment that should be used in a single application is 5 grams. If you use the 5% ointment, this is about 6 inches of ointment from the tube.
Children—Dose is based on body weight and must be determined by your doctor.
For topical dosage form (skin patch):
For pain caused by shingles:
Adults—Apply 1 to 3 patches to the painful area for up to 12 hours each day.
Children—Use and dose must be determined by your doctor.
For topical dosage form (solution):
For treatment of irritated or sore mouth or throat:
Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 milliliters (mL) tablespoonful every 3 hours. Your doctor may adjust your dose as needed. Do not use more than 8 doses in a 24-hour period.
Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor.
Children younger than 3 years of age—Dose is based on body weight and must be determined by your doctor. The dose should be no more than 1.2 mL applied to the immediate area with a cotton-tipped swab. Wait at least 3 hours between doses, and do not use more than 4 doses in a 12-hour period.
Missed Dose
If you miss a dose of Lidocaine (Dologel), apply 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.
If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
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.
After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.
Lidocaine (Dologel) 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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Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Lidocaine (Dologel) topical comes in many different forms for different uses. Lidocaine (Dologel) topical cream, lotion, spray, solution, film, and transdermal patch are generally for use on the skin only.
If your medication comes with patient instructions for safe and effective use, follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.
Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of Lidocaine (Dologel) topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.
Lidocaine (Dologel) topical may be applied with your finger tips or a cotton swab. Follow your doctor's instructions.
Do not apply this medication to swollen skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.
Store at room temperature away from moisture and heat.
Keep both used and unused Lidocaine (Dologel) topical patches out of the reach of children or pets. The amount of Lidocaine (Dologel) in the skin patches could be harmful to a child or pet who accidentally sucks on or swallows the patch. Seek emergency medical attention if this happens.
Lidocaine (Dologel) 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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Pharmacodynamics
Lidocaine (Dologel) is an amide-type local anesthetic agent and is suggested to stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses.
The penetration of Lidocaine (Dologel) into intact skin after application of Lidocaine (Dologel) is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block.
Pharmacokinetics
Absorption: The amount of Lidocaine (Dologel) systemically absorbed from Lidocaine (Dologel) is directly related to both the duration of application and the surface area over which it is applied. In a pharmacokinetic study, three Lidocaine (Dologel) Patches were applied over an area of 420 cm2 of intact skin on the back of normal volunteers for 12 hours. Blood samples were withdrawn for determination of Lidocaine (Dologel) concentration during the application and for 12 hours after removal of patches. The results are summarized in Table 1.
Table 1: Absorption of Lidocaine (Dologel) from Lidocaine (Dologel) Normal volunteers (n = 15, 12-hour wearing time)
Lidocaine (Dologel)
Patch
Application
Site
Area (cm2)
Dose Absorbed (mg)
Cmax
(mcg/mL)
Tmax
(hr)
3 patches
(2100 mg)
Back
420
64 ± 32
0.13 ± 0.06
11 hr
When Lidocaine (Dologel) is used according to the recommended dosing instructions, only 3 ± 2% of the dose applied is expected to be absorbed. At least 95% (665 mg) of Lidocaine (Dologel) will remain in a used patch. Mean peak blood concentration of Lidocaine (Dologel) is about 0.13 mcg/mL (about 1/10 of the therapeutic concentration required to treat cardiac arrhythmias). Repeated application of three patches simultaneously for 12 hours (recommended maximum daily dose), once per day for three days, indicated that the Lidocaine (Dologel) concentration does not increase with daily use. The mean plasma pharmacokinetic profile for the 15 healthy volunteers is shown in Figure 1.
Figure 1: Mean Lidocaine (Dologel) blood concentrations after three consecutive daily applications of three Lidocaine (Dologel) Patches simultaneously for 12 hours per day in healthy volunteers (n = 15).
Distribution: When Lidocaine (Dologel) is administered intravenously to healthy volunteers, the volume of distribution is 0.7 to 2.7 L/kg (mean 1.5 ± 0.6 SD, n = 15). At concentrations produced by application of Lidocaine (Dologel), Lidocaine (Dologel) is approximately 70% bound to plasma proteins, primarily alpha-1-acid glycoprotein. At much higher plasma concentrations (1 to 4 mcg/mL of free base), the plasma protein binding of Lidocaine (Dologel) is concentration dependent. Lidocaine (Dologel) crosses the placental and blood brain barriers, presumably by passive diffusion.
Metabolism: It is not known if Lidocaine (Dologel) is metabolized in the skin. Lidocaine (Dologel) is metabolized rapidly by the liver to a number of metabolites, including monoethylglycinexylidide (MEGX) and glycinexylidide (GX), both of which have pharmacologic activity similar to, but less potent than that of Lidocaine (Dologel). A minor metabolite, 2, 6-xylidine, has unknown pharmacologic activity but is carcinogenic in rats. The blood concentration of this metabolite is negligible following application of Lidocaine (Dologel) 5%. Following intravenous administration, MEGX and GX concentrations in serum range from 11 to 36% and from 5 to 11% of Lidocaine (Dologel) concentrations, respectively.
Excretion: Lidocaine (Dologel) and its metabolites are excreted by the kidneys. Less than 10% of Lidocaine (Dologel) is excreted unchanged. The half-life of Lidocaine (Dologel) elimination from the plasma following IV administration is 81 to 149 minutes (mean 107 ± 22 SD, n = 15). The systemic clearance is 0.33 to 0.90 L/min (mean 0.64 ± 0.18 SD, n = 15).
References
DailyMed. "MENTHOL; METHYL SALICYLATE: 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. "LIDOCAINE; TETRACAINE: 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. "IBUPROFEN: 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).
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