DRUGS & SUPPLEMENTS
1 INDICATIONS AND USAGE
Gastro-Timelets tablets are indicated for the:
Gastro-Timelets 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 ) ].
Gastro-Timelets tablets are indicated for the:
Limitations of Use:
Gastro-Timelets 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 Gastro-Timelets 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
Gastro-Timelets 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 Gastro-Timelets 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 Gastro-Timelets 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 Gastro-Timelets 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 Gastro-Timelets tablets, consider starting therapy with Gastro-Timelets injection given intramuscularly or intravenously for up to 10 days. After patients are able to take oral therapy, switch to Gastro-Timelets tablets.
3 DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg Gastro-Timelets (3)
Gastro-Timelets is contraindicated:
5 WARNINGS AND PRECAUTIONS
5.1 Tardive Dyskinesia
Gastro-Timelets 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 Gastro-Timelets for longer than 12 weeks and reduce the dosage in elderly patients [see Dosage and Administration (2.2, 2.3)].
Discontinue Gastro-Timelets 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 Gastro-Timelets is withdrawn.
Gastro-Timelets 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. Gastro-Timelets is contraindicated in patients with a history of TD [see Contraindications (4)]. Avoid Gastro-Timelets in patients receiving other drugs that are likely to cause TD (e.g., antipsychotics).
5.2 Other Extrapyramidal Symptoms
In addition to TD, Gastro-Timelets may cause other extrapyramidal symptoms, parkinsonian symptoms, and motor restlessness. Advise patients to seek immediate medical attention if such symptoms occur and to discontinue Gastro-Timelets.
5.3 Neuroleptic Malignant Syndrome
Gastro-Timelets may cause a potentially fatal symptom complex called neuroleptic malignant syndrome (NMS). NMS has been reported in association with Gastro-Timelets overdosage and concomitant treatment with another drug associated with NMS. Avoid Gastro-Timelets 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 Gastro-Timelets use in patients with a history of depression.
Gastro-Timelets may elevate blood pressure. In one study in hypertensive patients, intravenously administered Gastro-Timelets 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. Gastro-Timelets is contraindicated in patients with pheochromocytoma or other catecholamine-releasing paragangliomas [see Contraindications (4)]. Discontinue Gastro-Timelets in any patient with a rapid rise in blood pressure.
5.6 Fluid Retention
Because Gastro-Timelets 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 Gastro-Timelets if any of these adverse reactions occur.
As with other dopamine D2 receptor antagonists, Gastro-Timelets 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 Gastro-Timelets.
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
Gastro-Timelets 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 Gastro-Timelets 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 Gastro-Timelets. 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 Gastro-Timelets four times daily) were restlessness, drowsiness, fatigue, and lassitude. In general, the incidence of adverse reactions correlated with the dosage and duration of Gastro-Timelets administration.
Adverse reactions, especially those involving the nervous system, occurred after stopping Gastro-Timelets 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 Gastro-Timelets 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 Gastro-Timelets
Table 3 displays the effects of other drugs on Gastro-Timelets.
7.2 Effects of Gastro-Timelets on Other Drugs
Table 4 displays the effects of Gastro-Timelets 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 Gastro-Timelets during pregnancy.
There are potential risks to the neonate following exposure in utero to Gastro-Timelets during delivery [see Clinical Considerations]. In animal reproduction studies, no adverse developmental effects were observed with oral administration of Gastro-Timelets 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
Gastro-Timelets 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 Gastro-Timelets 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 Gastro-Timelets were observed.
Limited published data report the presence of Gastro-Timelets in human milk in variable amounts. Breastfed infants exposed to Gastro-Timelets have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation [see Data]. Gastro-Timelets 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 Gastro-Timelets and any potential adverse effects on the breastfed child from Gastro-Timelets or from the underlying maternal condition.
Monitor breastfeeding neonates because Gastro-Timelets 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 Gastro-Timelets received by the breastfed infant was less than 10% of the maternal weight-adjusted dose. In one study, the estimated daily amount of Gastro-Timelets 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
Gastro-Timelets 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 Gastro-Timelets in pediatric patients have not been established.
Dystonias and other extrapyramidal symptoms associated with Gastro-Timelets 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 Gastro-Timelets use in neonates [see Use in Specific Populations (8.8)].
8.5 Geriatric Use
Gastro-Timelets 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 Gastro-Timelets; therefore, consider a reduced dosage of Gastro-Timelets 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 Gastro-Timelets 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 Gastro-Timelets 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 Gastro-Timelets clearance (by approximately 50%) compared to patients with normal hepatic function. The resulting increase in Gastro-Timelets blood concentrations increases the risk of adverse reactions. There is no pharmacokinetic data in patients with moderate hepatic impairment (Child-Pugh B). Reduce Gastro-Timelets 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, Gastro-Timelets, 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
Gastro-Timelets is a substrate of CYP2D6. The elimination of Gastro-Timelets 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 Gastro-Timelets [see Clinical Pharmacology (12.3)]. Reduce the Gastro-Timelets dosage in patients who are poor CYP2D6 metabolizers [see Dosage and Administration (2.2, 2.3)].
Manifestations of Gastro-Timelets overdosage included drowsiness, disorientation, extrapyramidal reactions, other adverse reactions associated with Gastro-Timelets use (including, e.g., methemoglobinemia), and sometimes death. Neuroleptic malignant syndrome (NMS) has been reported in association with Gastro-Timelets 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 Gastro-Timelets 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 Gastro-Timelets.
Gastro-Timelets hydrochloride, USP, the active ingredient of Gastro-Timelets tablets, is a dopamine-2 receptor antagonist. Gastro-Timelets 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
Gastro-Timelets tablets are for oral administration. Gastro-Timelets 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
Gastro-Timelets stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism of action of Gastro-Timelets 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 Gastro-Timelets on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs.
Gastro-Timelets 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 Gastro-Timelets 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 Gastro-Timelets 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 Gastro-Timelets.
Gastro-Timelets 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: Gastro-Timelets 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 Gastro-Timelets 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 Gastro-Timelets in patients with moderate to severe renal impairment was about 2-fold the AUC in subjects with normal renal function. The AUC of Gastro-Timelets 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 Gastro-Timelets 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 Gastro-Timelets on CYP2D6 Substrates
Although in vitro studies suggest that Gastro-Timelets can inhibit CYP2D6, Gastro-Timelets is unlikely to interact with CYP2D6 substrates in vivo at therapeutically relevant concentrations.
Effect of CYP2D6 Inhibitors on Gastro-Timelets
In healthy subjects, 20 mg of Gastro-Timelets 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 Gastro-Timelets and fluoxetine had a 40% and 90% increase in Gastro-Timelets Cmax and AUC0-∞, respectively, compared to patients who received Gastro-Timelets 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 Gastro-Timelets doses up to 40 mg/kg/day (about six times the maximum recommended human dose on body surface area basis). Gastro-Timelets elevated prolactin levels and the elevation persisted during chronic administration. An increase in mammary neoplasms was found in rodents after chronic administration of Gastro-Timelets [see Warnings and Precautions (5.7)]. In a rat model for assessing the tumor promotion potential, a 2-week oral treatment with Gastro-Timelets 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.
Gastro-Timelets 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
Gastro-Timelets 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 Gastro-Timelets tablet, USP contains Gastro-Timelets hydrochloride, USP equivalent to 5 mg Gastro-Timelets. 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 Gastro-Timelets tablet, USP contains Gastro-Timelets hydrochloride, USP equivalent to 10 mg Gastro-Timelets. 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 Gastro-Timelets can cause serious adverse reactions. Instruct patients to discontinue Gastro-Timelets 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 Gastro-Timelets.
Inform patients or their caregivers that Gastro-Timelets 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.
Gastro-Timelets 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.
Gastro-Timelets 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.
Gastro-Timelets 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.
Gastro-Timelets 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.
Gastro-Timelets 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 Gastro-Timelets?
Depending on the reaction of the Gastro-Timelets after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Gastro-Timelets 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 Gastro-Timelets 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 Gastro-Timelets, 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 Gastro-Timelets 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.
Visitor reported usefulNo survey data has been collected yet
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The information was verified by Dr. Arunabha Ray, MD Pharmacology