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topiramate

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Overview

What is Topamax?

Topiramate is a sulfamate-substituted monosaccharide. TOPAMAX (topiramate) Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. TOPAMAX (topiramate capsules) Sprinkle Capsules are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food.

Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C H NO S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di- -isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:

TOPAMAX Tablets contain the following inactive ingredients: carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, sodium starch glycolate, synthetic iron oxide, and titanium dioxide.

TOPAMAX Sprinkle Capsules contain topiramate-coated beads in a hard gelatin capsule. The inactive ingredients are black pharmaceutical ink, cellulose acetate, gelatin, povidone, sodium lauryl sulfate, sorbitan monolaurate, sugar spheres (sucrose and starch) and titanium dioxide.



What does Topamax look like?



What are the available doses of Topamax?

TOPAMAX Tablets are available as debossed, coated, round tablets in the following strengths and colors:

25 mg cream (debossed "OMN" on one side; "25" on the other)

50 mg light-yellow (debossed "OMN" on one side; "50" on the other)

100 mg yellow (debossed "OMN" on one side; "100" on the other)

200 mg salmon (debossed "OMN" on one side; "200" on the other)

TOPAMAX Sprinkle Capsules contain small, white to off-white spheres. The gelatin capsules are white and clear.

They are marked as follows:

15 mg capsule with "TOP" and "15 mg" on the side

25 mg capsule with "TOP" and "25 mg" on the side

What should I talk to my health care provider before I take Topamax?

How should I use Topamax?

TOPAMAX is indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures.


What interacts with Topamax?

Sorry No Records found


What are the warnings of Topamax?

Sorry No Records found


What are the precautions of Topamax?

Sorry No Records found


What are the side effects of Topamax?

Sorry No records found


What should I look out for while using Topamax?

None.


What might happen if I take too much Topamax?

Overdoses of TOPAMAX have been reported. Signs and symptoms included convulsions, drowsiness, speech disturbance, blurred vision, diplopia, impaired mentation, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression. The clinical consequences were not severe in most cases, but deaths have been reported after overdoses involving TOPAMAX .

TOPAMAX overdose has resulted in severe metabolic acidosis .

A patient who ingested a dose of TOPAMAX between 96 and 110 g was admitted to a hospital with a coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days.

In acute TOPAMAX overdose, if the ingestion is recent, the stomach should be emptied immediately by lavage or by induction of emesis. Activated charcoal has been shown to adsorb topiramate . Hemodialysis is an effective means of removing topiramate from the body.


How should I store and handle Topamax?

10 mg TabletsAmlodipine Besylate Tablets, USP - 10 mg (Amlodipine besylate USP equivalent to 10 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "128" debossed on one side and "C" on other side and supplied as follows:StorageStore at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Protect from light and moisture.Manufactured by:Cipla, Ltd., Verna, Goa IndiaManufactured for: Cipla USA, Inc.1560 Sawgrass Corporate Parkway,Suite 130, Sunrise, FL 33323Revised: 12/2017Repackaged By: Preferred Pharmaceuticals Inc.10 mg TabletsAmlodipine Besylate Tablets, USP - 10 mg (Amlodipine besylate USP equivalent to 10 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "128" debossed on one side and "C" on other side and supplied as follows:StorageStore at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Protect from light and moisture.Manufactured by:Cipla, Ltd., Verna, Goa IndiaManufactured for: Cipla USA, Inc.1560 Sawgrass Corporate Parkway,Suite 130, Sunrise, FL 33323Revised: 12/2017Repackaged By: Preferred Pharmaceuticals Inc.10 mg TabletsAmlodipine Besylate Tablets, USP - 10 mg (Amlodipine besylate USP equivalent to 10 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "128" debossed on one side and "C" on other side and supplied as follows:StorageStore at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Protect from light and moisture.Manufactured by:Cipla, Ltd., Verna, Goa IndiaManufactured for: Cipla USA, Inc.1560 Sawgrass Corporate Parkway,Suite 130, Sunrise, FL 33323Revised: 12/2017Repackaged By: Preferred Pharmaceuticals Inc.10 mg TabletsAmlodipine Besylate Tablets, USP - 10 mg (Amlodipine besylate USP equivalent to 10 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "128" debossed on one side and "C" on other side and supplied as follows:StorageStore at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Protect from light and moisture.Manufactured by:Cipla, Ltd., Verna, Goa IndiaManufactured for: Cipla USA, Inc.1560 Sawgrass Corporate Parkway,Suite 130, Sunrise, FL 33323Revised: 12/2017Repackaged By: Preferred Pharmaceuticals Inc.10 mg TabletsAmlodipine Besylate Tablets, USP - 10 mg (Amlodipine besylate USP equivalent to 10 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "128" debossed on one side and "C" on other side and supplied as follows:StorageStore at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Protect from light and moisture.Manufactured by:Cipla, Ltd., Verna, Goa IndiaManufactured for: Cipla USA, Inc.1560 Sawgrass Corporate Parkway,Suite 130, Sunrise, FL 33323Revised: 12/2017Repackaged By: Preferred Pharmaceuticals Inc.10 mg TabletsAmlodipine Besylate Tablets, USP - 10 mg (Amlodipine besylate USP equivalent to 10 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "128" debossed on one side and "C" on other side and supplied as follows:StorageStore at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Protect from light and moisture.Manufactured by:Cipla, Ltd., Verna, Goa IndiaManufactured for: Cipla USA, Inc.1560 Sawgrass Corporate Parkway,Suite 130, Sunrise, FL 33323Revised: 12/2017Repackaged By: Preferred Pharmaceuticals Inc.10 mg TabletsAmlodipine Besylate Tablets, USP - 10 mg (Amlodipine besylate USP equivalent to 10 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "128" debossed on one side and "C" on other side and supplied as follows:StorageStore at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Protect from light and moisture.Manufactured by:Cipla, Ltd., Verna, Goa IndiaManufactured for: Cipla USA, Inc.1560 Sawgrass Corporate Parkway,Suite 130, Sunrise, FL 33323Revised: 12/2017Repackaged By: Preferred Pharmaceuticals Inc.10 mg TabletsAmlodipine Besylate Tablets, USP - 10 mg (Amlodipine besylate USP equivalent to 10 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "128" debossed on one side and "C" on other side and supplied as follows:StorageStore at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Protect from light and moisture.Manufactured by:Cipla, Ltd., Verna, Goa IndiaManufactured for: Cipla USA, Inc.1560 Sawgrass Corporate Parkway,Suite 130, Sunrise, FL 33323Revised: 12/2017Repackaged By: Preferred Pharmaceuticals Inc.10 mg TabletsAmlodipine Besylate Tablets, USP - 10 mg (Amlodipine besylate USP equivalent to 10 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "128" debossed on one side and "C" on other side and supplied as follows:StorageStore at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Protect from light and moisture.Manufactured by:Cipla, Ltd., Verna, Goa IndiaManufactured for: Cipla USA, Inc.1560 Sawgrass Corporate Parkway,Suite 130, Sunrise, FL 33323Revised: 12/2017Repackaged By: Preferred Pharmaceuticals Inc.10 mg TabletsAmlodipine Besylate Tablets, USP - 10 mg (Amlodipine besylate USP equivalent to 10 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "128" debossed on one side and "C" on other side and supplied as follows:StorageStore at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Protect from light and moisture.Manufactured by:Cipla, Ltd., Verna, Goa IndiaManufactured for: Cipla USA, Inc.1560 Sawgrass Corporate Parkway,Suite 130, Sunrise, FL 33323Revised: 12/2017Repackaged By: Preferred Pharmaceuticals Inc.10 mg TabletsAmlodipine Besylate Tablets, USP - 10 mg (Amlodipine besylate USP equivalent to 10 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "128" debossed on one side and "C" on other side and supplied as follows:StorageStore at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Protect from light and moisture.Manufactured by:Cipla, Ltd., Verna, Goa IndiaManufactured for: Cipla USA, Inc.1560 Sawgrass Corporate Parkway,Suite 130, Sunrise, FL 33323Revised: 12/2017Repackaged By: Preferred Pharmaceuticals Inc.10 mg TabletsAmlodipine Besylate Tablets, USP - 10 mg (Amlodipine besylate USP equivalent to 10 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "128" debossed on one side and "C" on other side and supplied as follows:StorageStore at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Protect from light and moisture.Manufactured by:Cipla, Ltd., Verna, Goa IndiaManufactured for: Cipla USA, Inc.1560 Sawgrass Corporate Parkway,Suite 130, Sunrise, FL 33323Revised: 12/2017Repackaged By: Preferred Pharmaceuticals Inc.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The precise mechanisms by which topiramate exerts its anticonvulsant and migraine prophylaxis effects are unknown; however, preclinical studies have revealed four properties that may contribute to topiramate's efficacy for epilepsy and migraine prophylaxis. Electrophysiological and biochemical evidence suggests that topiramate, at pharmacologically relevant concentrations, blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV.

Non-Clinical Toxicology
None.

Nifedipine is mainly eliminated by metabolism and is a substrate of CYP3A. Inhibitors and inducers of CYP3A can impact the exposure to nifedipine and consequently its desirable and undesirable effects. and data indicate that nifedipine can inhibit the metabolism of drugs that are substrates of CYP3A, thereby increasing the exposure to other drugs. Nifedipine is a vasodilator, and coadministration of other drugs affecting blood pressure may result in pharmacodynamic interactions.

A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving TOPAMAX . Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness), and increased intraocular pressure. Mydriasis may or may not be present. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating TOPAMAX therapy. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in pediatric patients as well as adults. The primary treatment to reverse symptoms is discontinuation of TOPAMAX as rapidly as possible, according to the judgment of the treating physician. Other measures, in conjunction with discontinuation of TOPAMAX , may be helpful.

Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

The data described in the following sections were obtained using TOPAMAX Tablets.

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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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Professional

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. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).