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OXTELLAR XR
Overview
What is OXTELLAR XR?
Oxtellar XR is an antiepileptic drug (AED). Oxtellar XR extended-release tablets contain oxcarbazepine for once-a-day oral administration.
Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is
Oxcarbazepine is off-white to yellow crystalline powder.
Oxcarbazepine is sparingly soluble in chloroform (30-100 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 40 mg/L (0.04 g/L) at pH 7.0, 25°C. The molecular formula is CHNO and its molecular weight is 252.27.
Oxtellar XR tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, yellow iron oxide (150 mg, 300 mg tablets only), red iron oxide (300 mg, 600 mg tablets only), black iron oxide (300 mg tablet only), magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium lauryl sulfate, talc, and titanium dioxide. Each tablet is printed on one side with edible black ink.
What does OXTELLAR XR look like?
What are the available doses of OXTELLAR XR?
Extended-release tablets:
What should I talk to my health care provider before I take OXTELLAR XR?
How should I use OXTELLAR XR?
Oxtellar XR is indicated as adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age.
Administer Oxtellar XR as a single daily dose taken on an empty stomach (at least 1 hour before or at least 2 hours after meals) [see ]. If Oxtellar XR is taken with food, adverse reactions are more likely to occur because of increased peak levels [see ].
Swallow Oxtellar XR tablets whole. Do not cut, crush, or chew the tablets. For ease of swallowing in pediatric patients or patients with difficulty swallowing, achieve daily dosages with multiples of appropriate lower strength tablets (e.g., 150 mg tablets).
What interacts with OXTELLAR XR?
Sorry No Records found
What are the warnings of OXTELLAR XR?
Sorry No Records found
What are the precautions of OXTELLAR XR?
Sorry No Records found
What are the side effects of OXTELLAR XR?
Sorry No records found
What should I look out for while using OXTELLAR XR?
Oxtellar XR is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components [see ].
What might happen if I take too much OXTELLAR XR?
How should I store and handle OXTELLAR XR?
Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [See USP controlled room temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container.Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 500 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D11" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.500 mg tablets: bottles of 100 - NDC# 68180-221-01 500 mg tablets: bottles of 1000 - NDC# 68180-221-03Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 750 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D12" on the other side. Tablets are supplied in bottles of 100 and 500s as shown below.750 mg tablets: bottles of 100 - NDC# 68180-222-01 750 mg tablets: bottles of 500 - NDC# 68180-222-02Niacin extended-release tablets USP are supplied as orange coloured, film-coated, oval-shaped tablets containing 1000 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D13" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.1000 mg tablets: bottles of 100 - NDC# 68180-223-01 1000 mg tablets: bottles of 1000 - NDC# 68180-223-03Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 500 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D11" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.500 mg tablets: bottles of 100 - NDC# 68180-221-01 500 mg tablets: bottles of 1000 - NDC# 68180-221-03Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 750 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D12" on the other side. Tablets are supplied in bottles of 100 and 500s as shown below.750 mg tablets: bottles of 100 - NDC# 68180-222-01 750 mg tablets: bottles of 500 - NDC# 68180-222-02Niacin extended-release tablets USP are supplied as orange coloured, film-coated, oval-shaped tablets containing 1000 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D13" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.1000 mg tablets: bottles of 100 - NDC# 68180-223-01 1000 mg tablets: bottles of 1000 - NDC# 68180-223-03Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 500 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D11" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.500 mg tablets: bottles of 100 - NDC# 68180-221-01 500 mg tablets: bottles of 1000 - NDC# 68180-221-03Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 750 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D12" on the other side. Tablets are supplied in bottles of 100 and 500s as shown below.750 mg tablets: bottles of 100 - NDC# 68180-222-01 750 mg tablets: bottles of 500 - NDC# 68180-222-02Niacin extended-release tablets USP are supplied as orange coloured, film-coated, oval-shaped tablets containing 1000 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D13" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.1000 mg tablets: bottles of 100 - NDC# 68180-223-01 1000 mg tablets: bottles of 1000 - NDC# 68180-223-03Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 500 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D11" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.500 mg tablets: bottles of 100 - NDC# 68180-221-01 500 mg tablets: bottles of 1000 - NDC# 68180-221-03Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 750 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D12" on the other side. Tablets are supplied in bottles of 100 and 500s as shown below.750 mg tablets: bottles of 100 - NDC# 68180-222-01 750 mg tablets: bottles of 500 - NDC# 68180-222-02Niacin extended-release tablets USP are supplied as orange coloured, film-coated, oval-shaped tablets containing 1000 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D13" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.1000 mg tablets: bottles of 100 - NDC# 68180-223-01 1000 mg tablets: bottles of 1000 - NDC# 68180-223-03Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 500 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D11" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.500 mg tablets: bottles of 100 - NDC# 68180-221-01 500 mg tablets: bottles of 1000 - NDC# 68180-221-03Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 750 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D12" on the other side. Tablets are supplied in bottles of 100 and 500s as shown below.750 mg tablets: bottles of 100 - NDC# 68180-222-01 750 mg tablets: bottles of 500 - NDC# 68180-222-02Niacin extended-release tablets USP are supplied as orange coloured, film-coated, oval-shaped tablets containing 1000 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D13" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.1000 mg tablets: bottles of 100 - NDC# 68180-223-01 1000 mg tablets: bottles of 1000 - NDC# 68180-223-03Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 500 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D11" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.500 mg tablets: bottles of 100 - NDC# 68180-221-01 500 mg tablets: bottles of 1000 - NDC# 68180-221-03Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 750 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D12" on the other side. Tablets are supplied in bottles of 100 and 500s as shown below.750 mg tablets: bottles of 100 - NDC# 68180-222-01 750 mg tablets: bottles of 500 - NDC# 68180-222-02Niacin extended-release tablets USP are supplied as orange coloured, film-coated, oval-shaped tablets containing 1000 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D13" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.1000 mg tablets: bottles of 100 - NDC# 68180-223-01 1000 mg tablets: bottles of 1000 - NDC# 68180-223-03Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 500 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D11" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.500 mg tablets: bottles of 100 - NDC# 68180-221-01 500 mg tablets: bottles of 1000 - NDC# 68180-221-03Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 750 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D12" on the other side. Tablets are supplied in bottles of 100 and 500s as shown below.750 mg tablets: bottles of 100 - NDC# 68180-222-01 750 mg tablets: bottles of 500 - NDC# 68180-222-02Niacin extended-release tablets USP are supplied as orange coloured, film-coated, oval-shaped tablets containing 1000 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D13" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.1000 mg tablets: bottles of 100 - NDC# 68180-223-01 1000 mg tablets: bottles of 1000 - NDC# 68180-223-03Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 500 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D11" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.500 mg tablets: bottles of 100 - NDC# 68180-221-01 500 mg tablets: bottles of 1000 - NDC# 68180-221-03Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 750 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D12" on the other side. Tablets are supplied in bottles of 100 and 500s as shown below.750 mg tablets: bottles of 100 - NDC# 68180-222-01 750 mg tablets: bottles of 500 - NDC# 68180-222-02Niacin extended-release tablets USP are supplied as orange coloured, film-coated, oval-shaped tablets containing 1000 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D13" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.1000 mg tablets: bottles of 100 - NDC# 68180-223-01 1000 mg tablets: bottles of 1000 - NDC# 68180-223-03Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 500 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D11" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.500 mg tablets: bottles of 100 - NDC# 68180-221-01 500 mg tablets: bottles of 1000 - NDC# 68180-221-03Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 750 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D12" on the other side. Tablets are supplied in bottles of 100 and 500s as shown below.750 mg tablets: bottles of 100 - NDC# 68180-222-01 750 mg tablets: bottles of 500 - NDC# 68180-222-02Niacin extended-release tablets USP are supplied as orange coloured, film-coated, oval-shaped tablets containing 1000 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D13" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.1000 mg tablets: bottles of 100 - NDC# 68180-223-01 1000 mg tablets: bottles of 1000 - NDC# 68180-223-03Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 500 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D11" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.500 mg tablets: bottles of 100 - NDC# 68180-221-01 500 mg tablets: bottles of 1000 - NDC# 68180-221-03Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 750 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D12" on the other side. Tablets are supplied in bottles of 100 and 500s as shown below.750 mg tablets: bottles of 100 - NDC# 68180-222-01 750 mg tablets: bottles of 500 - NDC# 68180-222-02Niacin extended-release tablets USP are supplied as orange coloured, film-coated, oval-shaped tablets containing 1000 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D13" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below.1000 mg tablets: bottles of 100 - NDC# 68180-223-01 1000 mg tablets: bottles of 1000 - NDC# 68180-223-03Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The pharmacological activity of Oxtellar XR is primarily exerted through the 10-monohydroxy metabolite (MHD) of oxcarbazepine [see ]. The precise mechanism by which oxcarbazepine and MHD exert their antiseizure effect is unknown; however, in vitro electrophysiological studies indicate that they produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. These actions are thought to be important in the prevention of seizure spread in the intact brain. In addition, increased potassium conductance and modulation of high-voltage activated calcium channels may contribute to the anticonvulsant effects of the drug. No significant interactions of oxcarbazepine or MHD with brain neurotransmitter or modulator receptor sites have been demonstrated.
Non-Clinical Toxicology
Oxtellar XR is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components [see ].Cromolyn sodium and isoproterenol were studied following subcutaneous injections in pregnant mice. Cromolyn sodium alone in doses up to 540 mg/kg (approximately 27 times the maximum recommended adult human daily inhalation dose on a mg/m basis) did not cause significant increases in resorptions or major malformations. Isoproterenol alone at a dose of 2.7 mg/kg (approximately 7 times the maximum recommended adult human daily inhalation dose on a mg/m basis) increased both resorptions and malformations. The addition of cromolyn sodium (approximately 27 times the maximum recommended adult human daily inhalation dose on a mg/m basis) to isoproterenol (approximately 7 times the maximum recommended adult human daily inhalation dose on a mg/m basis) appears to have increased the incidence of both resorptions and malformations.
Clinically significant hyponatremia (sodium <125 mmol/L) may develop during Oxtellar XR use. Serum sodium levels less than 125 mmol/L have occurred in immediate-release oxcarbazepine-treated patients generally in the first three months of treatment. However, clinically significant hyponatremia may develop more than a year after initiating therapy.
Most immediate-release oxcarbazepine-treated patients who developed hyponatremia were asymptomatic in clinical trials. However, some of these patients had their dose reduced, discontinued, or had their fluid intake restricted for hyponatremia. Serum sodium levels returned toward normal when the dosage was reduced or discontinued, or when the patient was treated conservatively (e.g., fluid restriction). Post-marketing cases of symptomatic hyponatremia have been reported during post-marketing use of immediate-release oxcarbazepine.
Among treated patients in a controlled trial of adjunctive therapy with Oxtellar XRin 366 adults with complex partial seizures, 1 patient receiving 2400 mg experienced a severe reduction in serum sodium (117 mEq/L) requiring discontinuation from treatment, while 2 other patients receiving 1200 mg experienced serum sodium concentrations low enough (125 and 126 mEq/L) to require discontinuation from treatment. The overall incidence of clinically significant hyponatremia in patients treated with Oxtellar XRwas 1.2%, although slight shifts in serum sodium concentrations from Normal to Low (<135 mEq/L) were observed for the 2400 mg (6.5%) and 1200 mg (9.8%) groups compared to placebo (1.7%). Measure serum sodium concentrations if patients develop symptoms of hyponatremia (e.g., nausea, malaise, headache, lethargy, confusion, obtunded consciousness, or increase in seizure frequency or severity). Consider measurement of serum sodium concentrations during treatment with Oxtellar XR, particularly if the patient receives concomitant medications known to decrease serum sodium levels (for example, drugs associated with inappropriate ADH secretion).
The following adverse reactions are described in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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