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Kapvay
Overview
What is Kapvay?
KAPVAY (clonidine hydrochloride) extended-release is a centrally acting alpha-adrenergic agonist available as 0.1 mg extended-release tablets for oral administration. Each 0.1 mg tablet is equivalent to 0.087 mg of the free base.
The inactive ingredients are sodium lauryl sulfate, lactose monohydrate, hypromellose type 2208, partially pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. The formulation is designed to delay the absorption of active drug in order to decrease peak to trough plasma concentration differences. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:
CHClN•HCl Mol. Wt. 266.56
Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.
What does Kapvay look like?
What are the available doses of Kapvay?
Extended-release tablets: 0.1 mg, not scored. ()
What should I talk to my health care provider before I take Kapvay?
How should I use Kapvay?
KAPVAY (clonidine hydrochloride) extended-release is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications .
KAPVAY is an extended-release tablet to be taken orally with or without food.
Due to the lack of controlled clinical trial data and differing pharmacokinetic profiles, substitution of KAPVAY for other clonidine products on a mg-per-mg basis is not recommended .
What interacts with Kapvay?
Sorry No Records found
What are the warnings of Kapvay?
Sorry No Records found
What are the precautions of Kapvay?
Sorry No Records found
What are the side effects of Kapvay?
Sorry No records found
What should I look out for while using Kapvay?
KAPVAY is contraindicated in patients with a history of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, and angioedema .
What might happen if I take too much Kapvay?
Symptoms
Clonidine overdose:
Treatment
Consult with a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice.
How should I store and handle Kapvay?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.KAPVAY extended-release tablets are round, white, non-scored, standard convex with debossing "651" on one side.NDC 59212-658-60 - 0.1 mg tablets supplied in a carton containing one bottle of 60 tablets.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight container.KAPVAY extended-release tablets are round, white, non-scored, standard convex with debossing "651" on one side.NDC 59212-658-60 - 0.1 mg tablets supplied in a carton containing one bottle of 60 tablets.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight container.KAPVAY extended-release tablets are round, white, non-scored, standard convex with debossing "651" on one side.NDC 59212-658-60 - 0.1 mg tablets supplied in a carton containing one bottle of 60 tablets.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight container.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Clonidine stimulates alpha-adrenergic receptors in the brain. Clonidine is not a central nervous system stimulant. The mechanism of action of clonidine in ADHD is not known.
Non-Clinical Toxicology
KAPVAY is contraindicated in patients with a history of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, and angioedema .Interactions between ethinyl estradiol and other substances may lead to decreased or increased serum ethinyl estradiol concentrations. Decreased ethinyl estradiol plasma concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the combination oral contraceptive.
Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Reduced ethinyl estradiol concentrations have been associated with concomitant use of substances that induce hepatic microsomal enzymes, such as rifampin, rifabutin, barbiturates, phenylbutazone, phenytoin sodium, griseofulvin, topiramate, some protease inhibitors, modafinil, and possibly St. John’s wort.
Substances that may decrease plasma ethinyl estradiol concentrations by other mechanisms include any substance that reduces gut transit time and certain antibiotics (e.g. ampicillin and other penicillins, tetracyclines) by a decrease of enterohepatic circulation of estrogens.
During concomitant use of ethinyl estradiol containing products and substances that may lead to decreased plasma steroid hormone concentrations, it is recommended that a nonhormonal back-up method of birth control be used in addition to the regular intake of Levora® 0.15/30-28 (levonorgestrel and ethinyl estradiol tablets). If the use of a substance which leads to decreased ethinyl estradiol plasma concentrations is required for a prolonged period of time, combination oral contraceptives should not be considered the primary contraceptive.
After discontinuation of substances that may lead to decreased ethinyl estradiol plasma concentrations, use of a nonhormonal back-up method of birth control is recommended for 7 days. Longer use of a back-up method is advisable after discontinuation of substances that have led to induction of hepatic microsomal enzymes, resulting in decreased ethinyl estradiol concentrations. It may take several weeks until enzyme induction has completely subsided, depending on dosage, duration of use, and rate of elimination of the inducing substance.
Some substances may increase plasma ethinyl estradiol concentrations. These include:
Ethinyl estradiol may interfere with the mechanism of other drugs by inhibiting hepatic microsomal enzymes or by inducing hepatic drug conjugation, particularly glucuronidation. Accordingly, tissue concentrations may be either increased (e.g. cyclosporine, theophylline, corticosteroids) or decreased.
The prescribing information of concomitant medications should be consulted to identify potential interactions.
Treatment with KAPVAY can cause dose-related decreases in blood pressure and heart rate . Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Titrate KAPVAY slowly in patients with a history of hypotension, and those with underlying conditions that may be worsened by hypotension and bradycardia; e.g., heart block, bradycardia, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. In patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration, advise patients to avoid becoming dehydrated or overheated. Monitor blood pressure and heart rate, and adjust dosages accordingly in patients treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope.
The following serious adverse reactions are described in greater detail elsewhere in 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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