DRUGS & SUPPLEMENTS
1 INDICATIONS AND USAGE
Metamol tablets are indicated for the:
Metamol tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations ( 8.4 ) ].
Metamol tablets are indicated for the:
Limitations of Use:
Metamol tablets are not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. (1, 8.4)
2 DOSAGE AND ADMINISTRATION
Acute and Recurrent Diabetic Gastroparesis (2.3)
Dosage Adjustment in Specific Populations (2.2, 2.3)
2.1 Important Administration Instructions
Avoid treatment with Metamol for longer than 12 weeks because of the increased risk of developing TD with longer-term use [see Dosage and Administration (2.2, 2.3), Warnings and Precautions (5.1)].
2.2 Dosage for Gastroesophageal Reflux
Metamol tablets may be administered continuously or intermittently in patients with symptomatic gastroesophageal reflux who fail to respond to conventional therapy:
The recommended adult dosage of Metamol is 10 to 15 mg four times daily for 4 to 12 weeks. The treatment duration is determined by endoscopic response. Administer the dosage thirty minutes before each meal and at bedtime. The maximum recommended daily dosage is 60 mg.
Table 1 displays the recommended daily dosage and maximum daily dosage for adults and dosage adjustments for patients with moderate or severe hepatic impairment, in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6 (CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors.
If symptoms only occur intermittently or at specific times of the day, administer Metamol in single dose up to 20 mg prior to the provoking situation. Consider dosage reductions for the populations and situations in Table 1.
2.3 Dosage for Acute and Recurrent Diabetic Gastroparesis
The recommended adult dosage for the treatment of acute and recurrent diabetic gastroparesis is 10 mg four times daily for 2 to 8 weeks, depending on symptomatic response. Avoid Metamol treatment for greater than 12 weeks [see Warnings and Precautions (5.1)]. Administer the dosage thirty minutes before each meal and at bedtime. The maximum recommended daily dosage is 40 mg.
Table 2 displays the recommended daily dosage and maximum daily dosage for adults and dosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B or C), in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6 (CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors.
If patients with diabetic gastroparesis have severe nausea or vomiting and are unable to take oral Metamol tablets, consider starting therapy with Metamol injection given intramuscularly or intravenously for up to 10 days. After patients are able to take oral therapy, switch to Metamol tablets.
3 DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg Metamol (3)
Metamol is contraindicated:
5 WARNINGS AND PRECAUTIONS
5.1 Tardive Dyskinesia
Metamol can cause tardive dyskinesia (TD), a syndrome of potentially irreversible and disfiguring involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities. Movements may be choreoathetotic in appearance. The risk of developing TD and the likelihood that TD will become irreversible increases with duration of treatment and total cumulative dosage. Additionally, the risk of developing TD is increased among the elderly, especially elderly women [see Use in Specific Populations (8.5)], and in patients with diabetes mellitus. Due to the risk of developing TD, avoid treatment with Metamol for longer than 12 weeks and reduce the dosage in elderly patients [see Dosage and Administration (2.2, 2.3)].
Discontinue Metamol immediately in patients who develop signs and symptoms of TD. There is no known effective treatment for established cases of TD, although in some patients TD may remit, partially or completely, within several weeks to months after Metamol is withdrawn.
Metamol itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown. Metamol is contraindicated in patients with a history of TD [see Contraindications (4)]. Avoid Metamol in patients receiving other drugs that are likely to cause TD (e.g., antipsychotics).
5.2 Other Extrapyramidal Symptoms
In addition to TD, Metamol may cause other extrapyramidal symptoms, parkinsonian symptoms, and motor restlessness. Advise patients to seek immediate medical attention if such symptoms occur and to discontinue Metamol.
5.3 Neuroleptic Malignant Syndrome
Metamol may cause a potentially fatal symptom complex called neuroleptic malignant syndrome (NMS). NMS has been reported in association with Metamol overdosage and concomitant treatment with another drug associated with NMS. Avoid Metamol in patients receiving other drugs associated with NMS, including typical and atypical antipsychotics.
Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and manifestations of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac arrhythmias). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Patients with such symptoms should be evaluated immediately.
In the diagnostic evaluation, consider the presence of other serious medical conditions (e.g., pneumonia, systemic infection) and untreated or inadequately treated extrapyramidal signs and symptoms. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever, serotonin syndrome, and primary central nervous system pathology.
Management of NMS includes:
Depression has occurred in metoclopramide-treated patients with and without a history of depression. Symptoms have included suicidal ideation and suicide. Avoid Metamol use in patients with a history of depression.
Metamol may elevate blood pressure. In one study in hypertensive patients, intravenously administered Metamol was shown to release catecholamines; hence, avoid use in patients with hypertension or in patients taking monoamine oxidase inhibitors [see Drug Interactions ].
There are also clinical reports of hypertensive crises in patients with undiagnosed pheochromocytoma. Metamol is contraindicated in patients with pheochromocytoma or other catecholamine-releasing paragangliomas [see Contraindications (4)]. Discontinue Metamol in any patient with a rapid rise in blood pressure.
5.6 Fluid Retention
Because Metamol produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart failure may be at risk of developing fluid retention and volume overload. Discontinue Metamol if any of these adverse reactions occur.
As with other dopamine D2 receptor antagonists, Metamol elevates prolactin levels.
Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating drugs, including Metamol.
Hyperprolactinemia may potentially stimulate prolactin-dependent breast cancer. However, some clinical studies and epidemiology studies have not shown an association between administration of dopamine D2 receptor antagonists and tumorigenesis in humans [see Nonclinical Toxicology ].
5.8 Effects of the Ability to Drive and Operate Machinery
Metamol may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. Concomitant use of central nervous system (CNS) depressants or drugs associated with EPS may increase this effect (e.g., alcohol, sedatives, hypnotics, opiates, and anxiolytics). Avoid Metamol or the interacting drug, depending on the importance of the drug to the patient [see Drug Interactions (7.1)].
6 ADVERSE REACTIONS
The following adverse reactions are described, or described in greater detail, in other sections of the labeling:
The following adverse reactions have been identified from clinical studies or postmarketing reports of Metamol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most common adverse reactions (in approximately 10% of patients receiving 10 mg of Metamol four times daily) were restlessness, drowsiness, fatigue, and lassitude. In general, the incidence of adverse reactions correlated with the dosage and duration of Metamol administration.
Adverse reactions, especially those involving the nervous system, occurred after stopping Metamol including dizziness, nervousness, and headaches.
Central Nervous System Disorders
Endocrine Disorders: Fluid retention secondary to transient elevation of aldosterone. Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia
Cardiovascular Disorders: Acute congestive heart failure, possible atrioventricular block, hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention
Gastrointestinal Disorders: Nausea, bowel disturbances (primarily diarrhea)
Hepatic Disorders: Hepatotoxicity, characterized by, e.g., jaundice and altered liver function tests, when Metamol was administered with other drugs with known hepatotoxic potential
Renal and Urinary Disorders: Urinary frequency, urinary incontinence
Hematologic Disorders: Agranulocytosis, neutropenia, leukopenia, methemoglobinemia, sulfhemoglobinemia
Hypersensitivity Reactions: Bronchospasm (especially in patients with a history of asthma), urticaria; rash; angioedema, including glossal or laryngeal edema
Eye Disorders: Visual disturbances
Metabolism Disorders: Porphyria
To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
7 DRUG INTERACTIONS
7.1 Effects of Other Drugs on Metamol
Table 3 displays the effects of other drugs on Metamol.
7.2 Effects of Metamol on Other Drugs
Table 4 displays the effects of Metamol on other drugs.
8 USE IN SPECIFIC POPULATIONS
Published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of Metamol during pregnancy.
There are potential risks to the neonate following exposure in utero to Metamol during delivery [see Clinical Considerations]. In animal reproduction studies, no adverse developmental effects were observed with oral administration of Metamol to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose [see Data].
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Fetal/Neonatal Adverse Reactions
Metamol crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with maternal administration during delivery. Monitor neonates for extrapyramidal signs [see Warnings and Precautions (5.1, 5.2), Use in Specific Populations (8.4)].
Reproduction studies have been performed following administration of oral Metamol during organogenesis in pregnant rats at about 6 times the MRHD calculated on body surface area and in pregnant rabbits at about 12 times the MRHD calculated on body surface area. No evidence of adverse developmental effects due to Metamol were observed.
Limited published data report the presence of Metamol in human milk in variable amounts. Breastfed infants exposed to Metamol have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation [see Data]. Metamol elevates prolactin levels [see Warnings and Precautions (5.7)]; however, the published data are not adequate to support drug effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Metamol and any potential adverse effects on the breastfed child from Metamol or from the underlying maternal condition.
Monitor breastfeeding neonates because Metamol may cause extrapyramidal signs (dystonias) and methemoglobinemia [see Warnings and Precautions (5.1, 5.2), Use in Specific Populations (8.4)].
In published clinical studies, the estimated amount of Metamol received by the breastfed infant was less than 10% of the maternal weight-adjusted dose. In one study, the estimated daily amount of Metamol received by infants from breast milk ranged from 6 to 24 mcg/kg/day in early puerperium (3 to 9 days postpartum) and from 1 to 13 mcg/kg/day at 8 to 12 weeks postpartum.
8.4 Pediatric Use
Metamol is not recommended for use in pediatric patients due to the risk of tardive dyskinesia and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. The safety and effectiveness of Metamol in pediatric patients have not been established.
Dystonias and other extrapyramidal symptoms associated with Metamol are more common in pediatric patients than in adults [see Warnings and Precautions (5.1, 5.2)]. In addition, neonates have reduced levels of NADH-cytochrome b5 reductase, making them more susceptible to methemoglobinemia, a possible adverse reaction of Metamol use in neonates [see Use in Specific Populations (8.8)].
8.5 Geriatric Use
Metamol is known to be substantially excreted by the kidney, and the risk of adverse reactions, including tardive dyskinesia (TD), may be greater in patients with impaired renal function [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. Elderly patients are more likely to have decreased renal function and may be more sensitive to the therapeutic or adverse effects of Metamol; therefore, consider a reduced dosage of Metamol in elderly patients [see Boxed Warning, Dosage and Administration (2.2, 2.3), Warnings and Precautions (5.1)].
8.6 Renal Impairment
The clearance of Metamol is decreased and the systemic exposure is increased in patients with moderate to severe renal impairment compared to patients with normal renal function, which may increase the risk of adverse reactions. Reduce the Metamol dosage in patients with moderate and severe renal impairment, including those receiving hemodialysis and continuous ambulatory peritoneal dialysis [see Dosage and Administration (2.2, 2.3), Clinical Pharmacology (12.3)].
8.7 Hepatic Impairment
Patients with severe hepatic impairment (Child-Pugh C) have reduced systemic Metamol clearance (by approximately 50%) compared to patients with normal hepatic function. The resulting increase in Metamol blood concentrations increases the risk of adverse reactions. There is no pharmacokinetic data in patients with moderate hepatic impairment (Child-Pugh B). Reduce Metamol dosage in patients with moderate or severe (Child-Pugh B or C) hepatic impairment [see Dosage and Administration (2.2, 2.3)]. There is no dosage adjustment required for patients with mild hepatic impairment (Child-Pugh A).
In addition, Metamol, by producing a transient increase in plasma aldosterone, may increase the risk of fluid retention in patients with hepatic impairment [see Warnings and Precautions (5.6)].
Monitor patients with hepatic impairment for the occurrence of fluid retention and volume overload.
8.8 NADH-Cytochrome b5 Reductase Deficiency
Metoclopramide-treated patients with NADH-cytochrome b5 reductase deficiency are at an increased risk of developing methemoglobinemia and/or sulfhemoglobinemia. For patients with glucose-6-phosphate dehydrogenase deficiency with metoclopramide-induced methemoglobinemia, methylene blue treatment is not recommended. Methylene blue may cause hemolytic anemia in patients with G6PD deficiency, which may be fatal [see Overdosage (10)].
8.9 CYP2D6 Poor Metabolizers
Metamol is a substrate of CYP2D6. The elimination of Metamol may be slowed in patients who are CYP2D6 poor metabolizers (compared to patients who are CYP2D6 intermediate, extensive, or ultra-rapid metabolizers); possibly increasing the risk of dystonic and other adverse reactions to Metamol [see Clinical Pharmacology (12.3)]. Reduce the Metamol dosage in patients who are poor CYP2D6 metabolizers [see Dosage and Administration (2.2, 2.3)].
Manifestations of Metamol overdosage included drowsiness, disorientation, extrapyramidal reactions, other adverse reactions associated with Metamol use (including, e.g., methemoglobinemia), and sometimes death. Neuroleptic malignant syndrome (NMS) has been reported in association with Metamol overdose and concomitant treatment with another drug associated with NMS [see Warnings and Precautions (5.1, 5.2, 5.3)].
There are no specific antidotes for Metamol overdosage. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
Methemoglobinemia can be reversed by the intravenous administration of methylene blue. However, methylene blue may cause hemolytic anemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, which may be fatal.
Hemodialysis and continuous ambulatory peritoneal dialysis do not remove significant amounts of Metamol.
Metamol hydrochloride, USP, the active ingredient of Metamol tablets, is a dopamine-2 receptor antagonist. Metamol hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows:
C14H22ClN3O2-HCl-H2O M.W. 354.3
Metamol tablets are for oral administration. Metamol tablets are available in 5 mg and 10 mg tablets.
Corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Metamol stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism of action of Metamol in the treatment of gastroesophageal reflux and acute and recurrent diabetic gastroparesis has not been fully established. It seems to sensitize tissues to the action of acetylcholine. The effect of Metamol on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs.
Metamol increases the tone and amplitude of gastric contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the lower esophageal sphincter. It has little, if any, effect on the motility of the colon or gallbladder.
In patients with gastroesophageal reflux and low lower esophageal sphincter pressure (LESP), single oral doses of Metamol produced dose-related increases in LESP. Effects began at about 5 mg and increased through 20 mg. The increase in LESP from a 5 mg dose lasted about 45 minutes and that of 20 mg lasted between 2 and 3 hours. Increased rate of stomach emptying was observed with single oral doses of 10 mg.
Relative to an intravenous dose of 20 mg, the absolute bioavailability of oral Metamol is 80% ± 15.5% as demonstrated in a crossover study of 18 subjects. Peak plasma concentrations occurred at about 1 to 2 hours after a single oral dose. Similar time to peak was observed after individual doses at steady state.
In a single dose study of 12 subjects, the area under the drug concentration-time curve increased linearly with doses from 20 to 100 mg (5 times the maximum recommended single dose). Peak concentrations increased linearly with dose; time to peak concentrations remained the same; whole body clearance was unchanged; and the elimination rate remained the same. The mean elimination half-life in subjects with normal renal function was 5 to 6 hours. Linear kinetic processes adequately describe the absorption and elimination of Metamol.
Metamol is not extensively bound to plasma proteins (about 30%). The whole body volume of distribution is high (about 3.5 L/kg), which suggests extensive distribution of drug to the tissues.
Metabolism: Metamol undergoes enzymatic metabolism via oxidation as well as glucuronide and sulfate conjugation reactions in the liver. Monodeethylmetoclopramide, a major oxidative metabolite, is formed primarily by CYP2D6, an enzyme subject to genetic variability [see Dosage and Administration (2.2, 2.3), Use in Specific Populations (8.9)].
Excretion: Approximately 85% of the radioactivity of an orally administered dose appeared in the urine within 72 hours. After oral administration of 10 or 20 mg, a mean of 18% and 22% of the dose, respectively, was recovered as free Metamol in urine within 36 hours.
Patients with Renal Impairment: In a study of 24 patients with varying degrees of renal impairment (moderate, severe, and end-stage renal disease (ESRD) requiring dialysis), the systemic exposure (AUC) of Metamol in patients with moderate to severe renal impairment was about 2-fold the AUC in subjects with normal renal function. The AUC of Metamol in patients with ESRD on dialysis was about 3.5-fold the AUC in subjects with normal renal function [see Dosage and Administration (2.2, 2.3) and Use in Specific Populations (8.6)].
Patients with Hepatic Impairment: In a group of 8 patients with severe hepatic impairment (Child-Pugh C), the average Metamol clearance was reduced by approximately 50% compared to patients with normal hepatic function [see Dosage and Administration (2.2, 2.3) and Use in Specific Populations (8.7)].
Drug Interaction Studies
Effect of Metamol on CYP2D6 Substrates
Although in vitro studies suggest that Metamol can inhibit CYP2D6, Metamol is unlikely to interact with CYP2D6 substrates in vivo at therapeutically relevant concentrations.
Effect of CYP2D6 Inhibitors on Metamol
In healthy subjects, 20 mg of Metamol and 60 mg of fluoxetine (a strong CYP2D6 inhibitor) were administered, following prior exposure to 60 mg fluoxetine orally for 8 days. The patients who received concomitant Metamol and fluoxetine had a 40% and 90% increase in Metamol Cmax and AUC0-∞, respectively, compared to patients who received Metamol alone [see Drug Interactions (7.1)].
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
A 77-week study was conducted in rats with oral Metamol doses up to 40 mg/kg/day (about six times the maximum recommended human dose on body surface area basis). Metamol elevated prolactin levels and the elevation persisted during chronic administration. An increase in mammary neoplasms was found in rodents after chronic administration of Metamol [see Warnings and Precautions (5.7)]. In a rat model for assessing the tumor promotion potential, a 2-week oral treatment with Metamol at a dose of 260 mg/kg/day (about 35 times the maximum recommended human dose based on body surface area) enhanced the tumorigenic effect of N-nitrosodiethylamine.
Metamol was positive in the in vitro Chinese hamster lung cell/HGPRT forward mutation assay for mutagenic effects and in the in vitro human lymphocyte chromosome aberration assay for clastogenic effects. It was negative in the in vitro Ames mutation assay, the in vitro unscheduled DNA synthesis assay with rat and human hepatocytes, and the in vivo rat micronucleus assay.
Impairment of Fertility
Metamol at intramuscular doses up to 20 mg/kg/day (about three times the maximum recommended human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats.
16 HOW SUPPLIED/STORAGE AND HANDLING
Each white, round, unscored, debossed “TV” on one side and “2204” on the other side, compressed Metamol tablet, USP contains Metamol hydrochloride, USP equivalent to 5 mg Metamol. Available in bottles of 100 (NDC 0093-2204-01) and 500 (NDC 0093-2204-05).
Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed Metamol tablet, USP contains Metamol hydrochloride, USP equivalent to 10 mg Metamol. Available in bottles of 100 (NDC 0093-2203-01), 500 (NDC 0093-2203-05), and 1000 (NDC 0093-2203-10).
Dispense in a tight, light-resistant container. Store tablets at 20° to 25°C (68° to 77°F).
This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Inform patients or their caregivers that Metamol can cause serious adverse reactions. Instruct patients to discontinue Metamol and contact a healthcare provider immediately if the following serious reactions occur:
Inform patients or their caregivers that concomitant treatment with numerous other medications can precipitate or worsen serious adverse reactions such as tardive dyskinesia or other extrapyramidal reactions, neuroleptic malignant syndrome, and CNS depression [see Drug Interactions (7.1, 7.2)]. Explain that the prescriber of any other medication must be made aware that the patient is taking Metamol.
Inform patients or their caregivers that Metamol can cause drowsiness or dizziness, or otherwise impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle [see Warnings and Precautions (5.8)].
Manufactured In Croatia By:
Pliva Hrvatska d.o.o.
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. Q 8/2017
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured In Croatia By:
Pliva Hrvatska d.o.o.
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. D 8/2017
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
Metamol pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Metamol available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Metamol destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Metamol Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Metamol pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Metamol?
Depending on the reaction of the Metamol after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Metamol not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Metamol addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Reviewsdrugs.com conducted a study on Metamol, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Metamol consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
One visitor reported usefulHow is the drug Metamol useful in reducing or relieving the symptoms? How useful is it?
According to the survey conducted by the website sdrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
Visitor reported side effectsNo survey data has been collected yet
One visitor reported price estimatesWhat is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sdrugs.com website users shows the following figures about several people who felt the medicine Metamol is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Visitor reported frequency of useNo survey data has been collected yet
Five visitors reported dosesWhat is the dose of Metamol drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 201-500mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
One visitor reported time for resultsWhat is the time duration Metamol drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed 3 days to notice the result from using Metamol drug. The time needed to show improvement in health condition after using the medicine Metamol need not be same for all the users. It varies based on other factors.
Visitor reported administrationNo survey data has been collected yet
Two visitors reported age
The information was verified by Dr. Arunabha Ray, MD Pharmacology