LORAZEPAM tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

LORAZEPAM (UNII: O26FZP769L) (LORAZEPAM - UNII:O26FZP769L)

Beszerezhető a:

NuCare Pharmaceuticals,Inc.

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Lorazepam tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam tablets USP in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. Lorazepam tablets are contraindicated in patients with - hypersensitivity to benzodiazepines or to any components of the formulation. - acute narrow-angle glaucoma.

Termék összefoglaló:

1 mg, white to off-white, round, flat-faced beveled edge tablets debossed with U33 on one side and bisect on other side. NDC 68071-5022-5 BOTTLES OF 15 DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER AS DESCRIBED IN THE USP. STORE AT 20°C to 25°C (68°to 77°F). [SEE USP CONTROLLED ROOM TEMPERATURE.] Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 Revised:11/2017 MEDICATION GUIDE LORAZEPAM Tablets, USP CIV What is the most important information I should know about LORAZEPAM? o Do not drive, operate heavy machinery, or do other dangerous activities until you know how LORAZEPAM affects you. o Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking LORAZEPAM without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, LORAZEPAM may make your sleepiness or dizziness much worse. What is LORAZEPAM? LORAZEPAM is a prescription medicine used: o to treat anxiety disorders o for the short-term relief of the symptoms of anxiety or anxiety that can happen with symptoms of depression LORAZEPAM is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep LORAZEPAM in a safe place to prevent misuse and abuse. Selling or giving away LORAZEPAM may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs. Do not take LORAZEPAM if you: Before you take LORAZEPAM, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking LORAZEPAM with certain other medicines can cause side effects or affect how well LORAZEPAM or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider. How should I take LORAZEPAM? What should I avoid while taking LORAZEPAM? What are the possible side effects of LORAZEPAM? LORAZEPAM may cause serious side effects, including: The most common side effects of LORAZEPAM include: sedation dizziness weakness unsteadiness These are not all the possible side effects of LORAZEPAM. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store LORAZEPAM? General information about the safe and effective use of LORAZEPAM. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LORAZEPAM for a condition for which it was not prescribed. Do not give LORAZEPAM to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about LORAZEPAM that is written for health professionals. What are the ingredients in LORAZEPAM? Active ingredient: lorazepam Inactive ingredients: anhydrous lactose, magnesium stearate, and microcrystalline cellulose and polacrilin potassium. This Medication Guide has been approved by the U.S. Food and Drug Administration Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 Revised:11/2017

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

LORAZEPAM- LORAZEPAM TABLET
NUCARE PHARMACEUTICALS,INC.
----------
LORAZEPAM TABLETS USP CIV
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound
sedation,
respiratory depression, coma, and death (see WARNINGS; PRECAUTIONS,
CLINICALLY SIGNIFICANT DRUG INTERACTIONS).
• Reserve concomitant prescribing of these drugs for use in patients
for whom
alternative treatment options are inadequate.
• Limit dosages and durations to the minimum required.
• Follow patients for signs and symptoms of respiratory depression
and sedation.
DESCRIPTION
Lorazepam, an antianxiety agent, has the chemical formula,
7-chloro-5-( _o_-
chlorophenyl)-1,3-dihydro-3-hydroxy-2 _H_-1,4-benzodiazepin-2-one:
It is a nearly white powder almost insoluble in water. Each lorazepam
tablet USP, to be
taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam USP. The
inactive ingredients
present are anhydrous lactose, magnesium stearate, microcrystalline
cellulose, and
polacriline potassium.
CLINICAL PHARMACOLOGY
Studies in healthy volunteers show that in single high doses lorazepam
has a
tranquilizing action on the central nervous system with no appreciable
effect on the
respiratory or cardiovascular systems.
Lorazepam is readily absorbed with an absolute bioavailability of 90
percent. Peak
concentrations in plasma occur approximately 2 hours following
administration. The
peak plasma level of lorazepam from a 2 mg dose is approximately 20
ng/mL.
The mean half-life of unconjugated lorazepam in human plasma is about
12 hours and
for its major metabolite, lorazepam glucuronide, about 18 hours. At
clinically relevant
concentrations, lorazepam is approximately 85% bound to plasma
proteins. Lorazepam
is rapidly conjugated at its 3-hydroxy group into lorazepam
glucuronide which is then
excreted in the urine. Lorazepam glucuronide has no demonstrable CNS
activity in
animals.
The plasma levels of lorazepam are proportional to the dose given.
There is no evidence
of accumulation of lorazepam