Oxigrex is an anticonvulsant, or antiepileptic drug. It works by decreasing nerve impulses that cause seizures.
Oxigrex is used either alone or with other medicines to treat partial seizures.
The Oxigrex brand of Oxigrex is used as a single medicine in adults and children who are at least 4 years old. Oxigrex is used with other medicines in adults and children who are at least 2 years old.
The Oxigrex brand of Oxigrex is used with other medicines in adults and children who are at least 6 years old.
Oxigrex may also be used for purposes not listed in this medication guide.
Oxigrex indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Oxigrex is indicated in adults and in children aged 1 month and above for the treatment of partial seizures (which include the seizure subtypes of simple, complex and partial seizures evolving to secondarily generalized seizures) and generalized tonic-clonic seizures.
Oxigrex is indicated as a first-line antiepileptic drug for use as monotherapy or adjunctive therapy.
Oxigrex can replace other antiepileptic drugs when current therapy provides insufficient seizure control.
How should I use Oxigrex?
Use Oxigrex suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Oxigrex suspension comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Oxigrex suspension refilled.
Take Oxigrex suspension by mouth with or without food.
Shake well before each use.
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
Oxigrex suspension may be mixed in a small glass of water just before taking/giving it or it may be swallowed directly from the syringe.
After each use, close the bottle and rinse the syringe with warm water. Allow it to dry thoroughly.
Taking Oxigrex suspension at the same times each day will help you remember to take it.
Continue to take Oxigrex suspension even if you feel well. Do not miss any doses. Oxigrex suspension works best when there is a constant level of it in your body.
If Oxigrex suspension is stopped, it should be done gradually as directed by your doctor. The risk of seizures may be increased if Oxigrex suspension is suddenly stopped.
If you miss a dose of Oxigrex suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Oxigrex suspension.
Uses of Oxigrex in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Focal (partial) onset seizures:
Immediate-release: Monotherapy or adjunctive therapy in the treatment of focal (partial) onset seizures in adults, as monotherapy in the treatment of focal (partial) onset seizures in children ≥4 years of age with epilepsy, and as adjunctive therapy in children ≥2 years of age with focal (partial) onset seizures.
Extended-release: Treatment of focal (partial) onset seizures in adults and in children ≥6 years of age.
Off Label Uses
Neuropathic pain
Data from a multicenter, double-blind, placebo-controlled study supports the use of Oxigrex monotherapy in the treatment of neuropathic pain of diabetic origin.
Oxigrex description
Each Oxigrex film-coated tablet contains 300 mg or 600 mg Oxigrex.
Each 1 mL of Oxigrex oral suspension contains 60 mg Oxigrex.
600 mg Tablet Coating only: Macrogol 4000; iron oxide red (E172); iron oxide black (E172).
Oral Suspension:
Propyl parahydroxybenzoate (E216), saccharin sodium, sorbic acid (E200), macrogol stearate 400, methyl parahydroxybenzoate (E218), yellow-plum-lemon flavour, ascorbic acid (E300), dispersible cellulose, propylene glycol, sorbitol 70% (non-crystallising), purified water. Ethanol is a component of the flavor.
Oxigrex dosage
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Oxigrex Dosage
Generic name: Oxigrex 150mg
Dosage form: tablet, film coated; oral suspension
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
All dosing should be given in a twice-a-day regimen. Oxigrex oral suspension and Oxigrex film-coated tablets may be interchanged at equal doses.
Oxigrex should be kept out of the reach and sight of children.
Before using Oxigrex oral suspension, shake the bottle well and prepare the dose immediately afterwards. The prescribed amount of oral suspension should be withdrawn from the bottle using the oral dosing syringe supplied. Oxigrex oral suspension can be mixed in a small glass of water just prior to administration or, alternatively, may be swallowed directly from the syringe. After each use, close the bottle and rinse the syringe with warm water and allow it to dry thoroughly.
Oxigrex can be taken with or without food.
2.1 Adjunctive Therapy for Adults
Treatment with Oxigrex should be initiated with a dose of 600 mg/day, given in a twice-a-day regimen. If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals; the recommended daily dose is 1200 mg/day. Daily doses above 1200 mg/day show somewhat greater effectiveness in controlled trials, but most patients were not able to tolerate the 2400 mg/day dose, primarily because of CNS effects. It is recommended that the patient be observed closely and plasma levels of the concomitant AEDs be monitored during the period of Oxigrex titration, as these plasma levels may be altered, especially at Oxigrex doses greater than 1200 mg/day.
2.2 Conversion to Monotherapy for Adults
Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with Oxigrex at 600 mg/day (given in a twice-a-day regimen) while simultaneously initiating the reduction of the dose of the concomitant AEDs. The concomitant AEDs should be completely withdrawn over 3-6 weeks, while the maximum dose of Oxigrex should be reached in about 2-4 weeks. Oxigrex may be increased as clinically indicated by a maximum increment of 600 mg/day at approximately weekly intervals to achieve the recommended daily dose of 2400 mg/day. A daily dose of 1200 mg/day has been shown in one study to be effective in patients in whom monotherapy has been initiated with Oxigrex. Patients should be observed closely during this transition phase.
2.3 Initiation of Monotherapy for Adults
Patients not currently being treated with AEDs may have monotherapy initiated with Oxigrex. In these patients, Oxigrex should be initiated at a dose of 600 mg/day (given in a twice-a-day regimen); the dose should be increased by 300 mg/day every third day to a dose of 1200 mg/day. Controlled trials in these patients examined the effectiveness of a 1200 mg/day dose; a dose of 2400 mg/day has been shown to be effective in patients converted from other AEDs to Oxigrex monotherapy.
2.4 Adjunctive Therapy for Pediatric Patients (Aged 2-16 Years)
In pediatric patients aged 4-16 years, treatment should be initiated at a daily dose of 8-10 mg/kg generally not to exceed 600 mg/day, given in a twice-a-day regimen. The target maintenance dose of Oxigrex should be achieved over two weeks, and is dependent upon patient weight, according to the following chart:
20-29 kg - 900 mg/day
29.1-39 kg - 1200 mg/day
>39 kg - 1800 mg/day
In the clinical trial, in which the intention was to reach these target doses, the median daily dose was 31 mg/kg with a range of 6-51 mg/kg.
In pediatric patients aged 2-<4 years, treatment should also be initiated at a daily dose of 8-10 mg/kg generally not to exceed 600 mg/day, given in a twice-a-day regimen. For patients under 20 kg, a starting dose of 16-20 mg/kg may be considered. The maximum maintenance dose of Oxigrex should be achieved over 2-4 weeks and should not exceed 60 mg/kg/day in a twice-a-day regimen.
In the clinical trial in pediatric patients (2 to 4 years of age) in which the intention was to reach the target dose of 60 mg/kg/day, 50% of patients reached a final dose of at least 55 mg/kg/day.
Under adjunctive therapy (with and without enzyme-inducing AEDs), when normalized by body weight, apparent clearance (L/hr/kg) decreased when age increased such that children 2 to <4 years of age may require up to twice the Oxigrex dose per body weight compared to adults; and children 4 to ≤12 years of age may require a 50% higher Oxigrex dose per body weight compared to adults.
2.5 Conversion to Monotherapy for Pediatric Patients (Aged 4-16 Years)
Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with Oxigrex at approximately 8-10 mg/kg/day given in a twice-a-day regimen, while simultaneously initiating the reduction of the dose of the concomitant antiepileptic drugs. The concomitant antiepileptic drugs can be completely withdrawn over 3-6 weeks while Oxigrex may be increased as clinically indicated by a maximum increment of 10 mg/kg/day at approximately weekly intervals to achieve the recommended daily dose. Patients should be observed closely during this transition phase.
The recommended total daily dose of Oxigrex is shown in the table below.
2.6 Initiation of Monotherapy for Pediatric Patients (Aged 4-16 Years)
Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with Oxigrex. In these patients, Oxigrex should be initiated at a dose of 8-10 mg/kg/day given in a twice-a-day regimen. The dose should be increased by 5 mg/kg/day every third day to the recommended daily dose shown in the table below.
Table 1 Range of Maintenance Doses of Oxigrex for Children by Weight During Monotherapy
From
To
Weight in kg
Dose (mg/day)
Dose (mg/day)
20
600
900
25
900
1200
30
900
1200
35
900
1500
40
900
1500
45
1200
1500
50
1200
1800
55
1200
1800
60
1200
2100
65
1200
2100
70
1500
2100
2.7 Patients with Hepatic Impairment
In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment
2.8 Patients with Renal Impairment
In patients with impaired renal function (creatinine clearance <30 mL/min) Oxigrex therapy should be initiated at one-half the usual starting dose (300 mg/day) and increased slowly to achieve the desired clinical response
Oxigrex can inhibit CYP2C19 and induce CYP3A4/5 with potentially important effects on plasma concentrations of other drugs. The inhibition of CYP2C19 by Oxigrex and MHD can cause increased plasma concentrations of drugs that are substrates of CYP2C19. Oxigrex and MHD induce a subgroup of the cytochrome P450 3A family (CYP3A4 and CYP3A5) responsible for the metabolism of dihydropyridine calcium antagonists, oral contraceptives and cyclosporine resulting in a lower plasma concentration of these drugs.
In addition, several AEDs that are cytochrome P450 inducers can decrease plasma concentrations of Oxigrex and MHD. No autoinduction has been observed with Oxigrex.
Antiepileptic Drugs
Potential interactions between Oxigrex and other AEDs were assessed in clinical studies. The effect of these interactions on mean AUCs and Cmin are summarized in Table 7.
Table 7 : Summary of AED Interactions with Oxigrex
AED Coadministered
Dose of AED (mg/day)
Oxigrex Dose (mg/day)
Influence of Oxigrex on AED Concentration (Mean Change, 90% Confidence Interval)
Influence of AED on MHD Concentration (Mean Change, 90% Confidence Interval)
Carbamazepine
400-2000
900
ncMean increase in adults at high Oxigrex doses
In vivo, the plasma levels of phenytoin increased by up to 40% when Oxigrex was given at doses above 1200 mg/day. Therefore, when using doses of Oxigrex greater than 1200 mg/day during adjunctive therapy, a decrease in the dose of phenytoin may be required. The increase of phenobarbital level, however, is small (15%) when given with Oxigrex.
Strong inducers of cytochrome P450 enzymes (i.e., carbamazepine, phenytoin and phenobarbital) have been shown to decrease the plasma levels of MHD (29%-40%).
No autoinduction has been observed with Oxigrex.
Hormonal Contraceptives
Coadministration of Oxigrex with an oral contraceptive has been shown to influence the plasma concentrations of the two hormonal components, ethinylestradiol (EE) and levonorgestrel (LNG). The mean AUC values of EE were decreased by 48% [90% CI: 22-65] in one study and 52% [90% CI: 38-52] in another study. The mean AUC values of LNG were decreased by 32% [90% CI: 20-45] in one study and 52% [90% CI: 42-52] in another study. Therefore, concurrent use of Oxigrex with hormonal contraceptives may render these contraceptives less effective. Studies with other oral or implant contraceptives have not been conducted.
Calcium Antagonists
After repeated coadministration of Oxigrex, the AUC of felodipine was lowered by 28% [90% CI: 20-33]. Verapamil produced a decrease of 20% [90% CI: 18-27] of the plasma levels of MHD.
Other Drug Interactions
Cimetidine, erythromycin and dextropropoxyphene had no effect on the pharmacokinetics of MHD. Results with warfarin show no evidence of interaction with either single or repeated doses of Oxigrex.
Drug/Laboratory Test Interactions
There are no known interactions of Oxigrex with commonly used laboratory tests.
Drug Abuse And Dependence
Abuse
The abuse potential of Oxigrex has not been evaluated in human studies.
Dependence
Intragastric injections of Oxigrex to four cynomolgus monkeys demonstrated no signs of physical dependence as measured by the desire to self-administer Oxigrex by lever pressing activity.
The following adverse reactions are described in other sections of the labeling:
Hyponatremia
Anaphylactic Reactions and Angioedema
Hypersensitivity Reactions in Patients with Hypersensitivity to Carbamazepine
Serious Dermatological Reactions
Suicidal Behavior and Ideation
Withdrawal of AEDs
Multi-Organ Hypersensitivity
Hematologic Reactions
Risk of Seizures in the Pregnant Patient
Laboratory Tests
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety data presented below are from 384 patients with partial epilepsy who received Oxigrex® (366 adults and 18 children) with concomitant AEDs.
In addition, safety data presented below are from a total of 2,288 patients with seizure disorders treated with immediate-release Oxigrex; 1,832 were adults and 456 were children.
Most Common Adverse Reactions Reported by Adult Patients Receiving Concomitant AEDs in Oxigrex® Clinical Studies
Table 3 lists adverse reactions that occurred in at least 2% of adult patients with epilepsy treated with Oxigrex® or placebo and concomitant AEDs and that were numerically more common in the patients treated with any dose of Oxigrex® than in patients receiving placebo.
The overall incidence of adverse reactions appeared to be dose related, particularly during the titration period. The most commonly observed ( ≥ 5%) adverse reactions seen in association with Oxigrex® and more frequent than in placebo-treated patients were: dizziness, somnolence, headache, balance disorder, tremor, vomiting, diplopia, and asthenia.
Table 3: Adverse Reaction Incidence in a Controlled Clinical Study of Oxigrex® with Concomitant AEDs in Adults*
Oxigrex® 2400 mg/day
N=123
%
Oxigrex® 1200 mg/day
N=122
%
Placebo
N=121
%
Any System / Any Term
69
57
55
Nervous System Disorders
Dizziness
41
20
15
Somnolence
14
12
9
Headache
15
8
7
Balance Disorder
7
5
5
Tremor
1
5
2
Nystagmus
3
3
1
Ataxia
1
3
1
Gastrointestinal Disorders
Vomiting
15
6
9
Abdominal Pain Upper
0
3
1
Dyspepsia
0
3
1
Gastritis
0
3
2
Eye Disorders
Diplopia
13
10
4
Vision Blurred
1
4
3
Visual Impairment
1
3
0
General Disorders And Administration Site Conditions
Asthenia
7
3
1
Fatigue
3
6
1
Gait Disturbance
0
3
1
Drug Intolerance
2
0
0
Infections And Infestations
Nasopharyngitis
0
3
0
Sinusitis
0
3
2
* Reported by ≥ 2% of Patients Treated with Oxigrex® and Numerically More Frequent than in the Placebo Group
Adverse Reactions Associated with Discontinuation of Oxigrex® Treatment
Approximately 23.3% of the 366 adult patients receiving Oxigrex® in clinical studies discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation of Oxigrex® (reported by ≥ 2%) were: dizziness (9.8%), vomiting (5.3%), nausea (3.7%), diplopia (3.2%), and somnolence (2.4%).
Adjunctive Therapy with Oxigrex® in Pediatric Patients 4 to 16 Years Old Previously Treated with other AEDs
In a pharmacokinetic study in 18 children (age 4-16 years) with partial seizures treated with different doses of Oxigrex®, the observed adverse reactions seen in association with Oxigrex® were similar to those seen in adults.
Most Common Adverse Reactions in Immediate-Release Oxigrex Controlled Clinical Studies
Controlled Clinical Studies of Adjunctive Therapy with Immediate-Release Oxigrex in Adults Previously Treated with other AEDs: Table 4 lists adverse reactions that occurred in at least 2% of adult patients with epilepsy treated with immediate-release Oxigrex or placebo with concomitant AEDs and that were numerically more common in the patients treated with any dose of immediate-release Oxigrex than in placebo. As immediate-release Oxigrex and Oxigrex® were not examined in the same trial, adverse event frequencies cannot be directly compared between the two formulations.
Table 4: Adverse Reaction Incidence in a Controlled Clinical Study of Immediate Release Oxigrex with Concomitant AEDs in Adults*
Immediate-Release Oxigrex Dosage (mg/day)
Placebo
N = 166
%
OXC 600
N = 163
%
OXC 1200
N = 171
%
OXC 2400
N = 126
%
Body as a Whole
Fatigue
15
12
15
7
Asthenia
6
3
6
5
Edema Legs
2
1
2
1
Weight Increase
1
2
2
1
Feeling Abnormal
0
1
2
0
Cardiovascular System
Hypotension
0
1
2
0
Digestive System
Nausea
15
25
29
10
Vomiting
13
25
36
5
Pain Abdominal
10
13
11
5
Diarrhea
5
6
7
6
Dyspepsia
5
5
6
2
Constipation
2
2
6
4
Gastritis
2
1
2
1
Metabolic and Nutritional Disorders
Hyponatremia
3
1
2
1
Musculoskeletal System
Muscle Weakness
1
2
2
0
Sprains and Strains
0
2
2
1
Nervous System
Headache
32
28
26
23
Dizziness
36
32
49
13
Somnolence
20
28
36
12
Ataxia
9
17
31
5
Nystagmus
7
20
26
5
Gait Abnormal
5
10
17
1
Insomnia
4
2
3
1
Tremor
3
8
16
5
Nervousness
2
4
2
1
Agitation
1
1
2
1
Coordination Abnormal
1
3
2
1
EEG Abnormal
0
0
2
0
Speech Disorder
1
1
3
0
Confusion
1
1
2
1
Cranial Injury NOS
1
0
2
1
Dysmetria
1
2
3
0
Thinking Abnormal
0
2
4
0
Respiratory System
Rhinitis
2
4
5
4
Skin and Appendages
Acne
1
2
2
0
Special Senses
Diplopia
14
30
40
5
Vertigo
6
12
15
2
Vision Abnormal
6
14
13
4
Accommodation Abnormal
0
0
2
0
* Events in at Least 2% of Patients Treated with 2400mg/day of Immediate-Release Oxigrex and Numerically More Frequent than in the Placebo Group
Other Reactions Observed in Association with the Administration of Immediate-Release Oxigrex
In the paragraphs that follow, the adverse reactions, other than those in the preceding tables or text, that occurred in a total of 565 children and 1,574 adults exposed to immediate-release Oxigrex and that are reasonably likely to be related to drug use are presented. Events common in the population, events reflecting chronic illness and events likely to reflect concomitant illness are omitted particularly if minor. They are listed in order of decreasing frequency. Because the reports cite reactions observed in open label and uncontrolled trials, the role of immediate-release Oxigrex in their causation cannot be reliably determined.
Body as a Whole: fever, malaise, pain chest precordial, rigors, weight decrease.
The following adverse reactions have been observed in named patient programs or post-marketing experience with immediate-release Oxigrex or Oxigrex®. 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.
Body as a Whole: multi-organ hypersensitivity disorders characterized by features such as rash, fever, lymphadenopathy, abnormal liver function tests, eosinophilia and arthralgia
Musculoskeletal, connective tissue and bone disorders: There have been reports of decreased bone mineral density, osteoporosis and fractures in patients on long-term therapy with immediate-release Oxigrex.
You should not take this medication if you are allergic to Oxigrex.
Before you take Oxigrex, tell your doctor if you have liver or kidney disease.
Oxigrex can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking Oxigrex.
Oxigrex can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Contact your doctor right away if you have headache, problems with thinking or memory, weakness, loss of appetite, feeling unsteady, confusion, hallucinations, fainting, shallow breathing, and/or increased or more severe seizures.
You may have thoughts about suicide when you first start taking this medicine. Your doctor will need to check you at regular visits.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
There are many other medicines that can interact with Oxigrex. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
DailyMed. "OXCARBAZEPINE: 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).
The results of a survey conducted on ndrugs.com for Oxigrex are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Oxigrex. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
User reports
1 consumer reported useful
Was the Oxigrex drug useful in terms of decreasing the symptom or the disease? According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
Users
%
Useful
1
100.0%
Consumer reported price estimates
No survey data has been collected yet
Consumer reported time for results
No survey data has been collected yet
Consumer reported age
No survey data has been collected yet
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