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LORAVAN TABLET CONTAINS 0.5 MG, 1 MG, OF LORAZEPAM USP. THE INACTIVE INGREDIENTS PRESENT ARE
LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, MICROCRYSTALLINE
CELLULOSE, POLACRILINE POTASSIUM. GENERIC NAME AND FORMULATIONS: LORAVAN
INJECTION FOR I.M./ I.V. USE LORAZEPAM 2MG/ML, 4MG/ML;
SOLN FOR IV INJ AFTER DILUTION OR IM INJ;
CONTAINS POLYETHYLENE GLYCOL 400 IN PROPYLENE GLYCOL, BENZYL
ALCOHOL.
Indications for LORAZEPAM INJECTION:
Preanesthetic to produce sedation, anxiety relief, and
diminished recall of events related to surgery.
Adult:
Individualize. ≥18yrs: IM: Give 2 hours prior to surgery.
0.05mg/kg, max 4mg. IV: Give 15–20 minutes prior to surgery.
0.044mg/kg or 2mg total, whichever is lower, may increase dose
to 0.05mg/kg up to max 4mg if diminished recall of events
related to surgery is desired; >50yrs: max IV dose of 0.044mg/kg
or 2mg total, whichever is lower.
Children:
<18yrs: not recommended.
Contraindications:
Acute narrow-angle glaucoma. Sleep apnea. Severe respiratory
insufficiency (except as preanesthetic during mechanical
ventilation). Intra-arterial injection.
Warnings/Precautions:
Monitor respiration and level of sedation; ensure availability
of resuscitative equipment for ventilatory support. Fall risk.
Critically ill. Limited pulmonary reserve. Hepatic or renal
failure: not recommended; caution with mild to moderate
hepatic/renal disease. Elderly. Avoid extravasation. Outpatient
endoscopy. Labor and delivery, pregnancy (Cat.D), nursing
mothers: not recommended.
Interactions:
Additive CNS effects with alcohol, phenothiazines, narcotic
analgesics, barbiturates, antidepressants, and MAOIs. Caution
with concurrent administration of scopolamine, loxapine,
clozapine, haloperidol, or other CNS depressant drugs. May be
antagonized by oral contraceptives (may need to increase
lorazepam dose). Potentiated by valproate and probenecid (reduce
lorazepam dose by 50%).
Pharmacological Class:
Benzodiazepine.
Adverse Reactions:
Respiratory depression/failure, hypotension, somnolence,
headache, apnea, excessive sleepiness and drowsiness, inj site
reaction, paradoxical reactions.
INDICATIONS FOR TABLETS
Loravan is 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.
DOSAGE AND ADMINISTRATION
Loravan is administered orally. For optimal results, dose,
frequency of administration, and duration of therapy should be
individualized according to patient response. To facilitate this,
0.5 mg, 1 mg, and 2 mg tablets are available.
The usual range is 2 to 6 mg/day given in divided doses, the
largest dose being taken before bedtime, but the daily dosage may
vary from 1 to 10 mg/day.
For anxiety, most patients require an initial dose of 2 to 3
mg/day given b.i.d. or t.i.d.
For insomnia due to anxiety or transient situational stress, a
single daily dose of 2 to 4 mg may be given, usually at bedtime.
For elderly or debilitated patients, an initial dosage of 1 to 2
mg/day in divided doses is recommended, to be adjusted as needed
and tolerated.
The dosage of Loravan should be increased gradually when
needed to help avoid adverse effects. When higher dosage is
indicated, the evening dose should be increased before the daytime
doses.
WARNINGS
Pre-existing depression may emerge or worsen during use of
benzodiazepines including lorazepam. Loravan is not
recommended for use in patients with a primary depressive disorder
or psychosis.
Use of benzodiazepines, including lorazepam, both used alone and
in combination with other CNS depressants, may lead to potentially
fatal respiratory depression. (See PRECAUTIONS, Clinically
Significant Drug Interactions)
Use of benzodiazepines, including lorazepam, may lead to physical
and psychological dependence.
CONTRAINDICATIONS
Loravan is contraindicated in patients with
* hypersensitivity to benzodiazepines or to any components of the
formulation.
* acute narrow-angle glaucoma.
SIDE EFFECTS
Drowsiness, dizziness, loss of coordination, headache, nausea,
blurred vision, change in sexual interest/ability, hair loss,
constipation, heartburn, or change in appetite may occur. If any
of these effects persist or worsen, notify your doctor or
pharmacist promptly.
Remember that your doctor has prescribed this medication because
he or she has judged that the benefit to you is greater than the
risk of side effects. Many people using this medication do not
have serious side effects.
STORAGE
Store at room temperature between 68-77 degrees F (20-25 degrees
C) away from light and moisture. Do not store in the bathroom.
Keep all medicines away from children
Presentation
Loravan
Tablets Strip of 10 Tablets
How Supplied: LORAVAN INJECTION
Single-use vials—25
Multiple-dose vials (10mL)—10
SCHEDULE IV CONTROLLED SUBSTANCES : Controlled Substances
Import and Export Act
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
"Placement on schedules; findings required Schedule IV
substances are those that have the following findings:The
drug or other substance has a low potential for abuse
relative to the drugs or other substances in schedule III.
The drug or other substance has a currently accepted medical
use in treatment in the United StatesAbuse of the drug or
other substance may lead to limited physical dependence or
psychological dependence relative to the drugs or other
substances in schedule III.Control measures are similar to
Schedule III. Prescriptions for Schedule IV drugs may be
refilled up to five times within a six-month period. A
prescription for controlled substances in Schedules III, IV,
and V issued by a practitioner, may be communicated either
orally, in writing, or by facsimile to the pharmacist, and
may be refilled if so authorized on the prescription or by
call-in. DRUGS IN THIS SCHEDULE INCLUDE:Benzodiazepines,
such as ALPRAZOLAM (Xanax), chlordiazepoxide (Librium),
clonazepam (Klonopin), diazepam (Valium), and Lorazepam (Ativan),
as well as:temazepam (Restoril) (note that some states
require specially coded prescriptions for temazepam)
flunitrazepam (Rohypnol) (note that flunitrazepam is not
used medically in the United States). The
benzodiazepine-like Z-drugs: zolpidem (Ambien), zopiclone (Imovane),
eszopiclone (Lunesta), and zaleplon (Sonata) (zopiclone is
not commercially available in the U.S.) Chloral hydrate, a
sedative-hypnotic, Long-acting barbiturates such as
phenobarbitalSome partial agonist opioid analgesics, such as
pentazocine (Talwin) The stimulant-like drug modafinil (sold
in the U.S. as Provigil) as well as its (R)-enantiomer
armodafinil (sold in the U.S. as Nuvigil)
Difenoxin, an antidiarrheal drug, such as when combined with
atropine (Motofen) (difenoxin is 2–3 times more potent than
diphenoxylate, the active ingredient in Lomotil, which is in
Schedule V)
Tramadol (Ultram) / Carisoprodol (Soma) has become a
Schedule IV medication as of 11 January 2012.
Section 1000 [951 note] Short Title
This title may be cited as the "Controlled Substances Import
and Export Act.'' EXPORT IS SUBJECTED TO NOC (Narcotic Drugs
Import and Export Act) INDIA.
Export/ Import
ANY NARCOTIC DRUGS OR PSYCHOTROPIC SUBSTANCES CAN BE
IMPORTED INTO/ EXPORTED OUT OF INDIA SUBJECT TO RULE 53 AND
RULE 53-A OF THE NDPS RULES, 1985.
The import of - (i) opium, concentrate of poppy straw, and
(ii) morphine, codeine, thebaine, and their salts is
prohibited save by the Government Opium Factory under the
provision of Rule 54 of the NDPS Rules, 1985. The import
into and export out of India of any narcotic drugs or
psychotropic substances specified in Schedule I is
prohibited under the provision of Rule 53 of the NDPS Rules,
1985. The export of any narcotic drugs or psychotropic
substances or preparations containing any of such narcotic
drugs or psychotropic substances specified in Schedule II
shall be prohibited to the countries or to the region of
such country specified therein under the provision of Rule
53-A of the NDPS Rules, 1985.The manufacture of psychotropic
substances specified in Schedule III can be allowed for
export purpose only under the provision of Rule 65(1) of the
NDPS Rules, 1985. The import of psychotropic substances
specified in Schedule III may be allowed for test/ analysis
purpose as well as for re-export purpose. The export out of
/ import into India of a select number of Precursor
Chemicals is exercised by the Narcotics Commissioner in
accordance with Directorate General of Foreign Trade (DGFT)
notification and Administrative Control.
ANY COMPANY/APPLICANT DESIROUS OF OBTAINING NO OBJECTION
CERTIFICATE FOR EXPORT OF NOTIFIED PRECURSOR CHEMICALS ARE
REQUIRED TO APPLY TO THE NARCOTICS COMMISSIONER. (UNDER
RULES FROM CENTRAL BUREAU OF NARCOTICS, GOVERNMENT OF INDIA)
Note :
This product information is intended only
for residents of the India. Taj Pharmaceuticals Limited,
medicines help to treat and prevent a range of conditions—from the
most common to the most challenging—for people around the world.
Information for Health Care Professionals
*** Please consult local Prescribing
Information for any product before use. This website is an
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professional. Above brand is a trademark of the Taj group of
companies (Taj Pharmaceuticals Limited).
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